Full Press Release Details
SAN RAFAEL, Calif. , Aug. 2, 2018 /PRNewswire/ --
| Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) | ||||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||
| 2018 | 2017 | % Change | 2018 | 2017 | % Change | |||||||||||||||||||
| Total Revenues | $ | 372.8 | $ | 317.4 | 17 | % | $ | 746.3 | $ | 621.2 | 20 | % | ||||||||||||
| Vimizim Net Product Revenues | 127.6 | 103.2 | 24 | % | 244.7 | 209.0 | 17 | % | ||||||||||||||||
| Kuvan Net Product Revenues | 109.0 | 102.0 | 7 | % | 208.1 | 194.3 | 7 | % | ||||||||||||||||
| Naglazyme Net Product Revenues | 91.1 | 85.7 | 6 | % | 166.1 | 166.3 | — | |||||||||||||||||
| Aldurazyme Net Product Revenues | 24.0 | 19.9 | 21 | % | 90.1 | 39.3 | 129 | % | ||||||||||||||||
| Brineura Net Product Revenues | 10.9 | 0.3 | n/a | 17.8 | 0.3 | n/a | ||||||||||||||||||
| GAAP Net Loss | $ | (16.8) | $ | (36.8) | $ | (60.9) | $ | (53.1) | ||||||||||||||||
| GAAP Net Loss per Share - Basic and Diluted | $ | (0.09) | $ | (0.21) | $ | (0.35) | $ | (0.31) | ||||||||||||||||
| Non-GAAP Income (1) | $ | 19.9 | $ | 26.6 | $ | 41.2 | $ | 61.0 | ||||||||||||||||
| June 30, | December 31, | |||||||||||||||||||||||
| 2018 | 2017 | |||||||||||||||||||||||
| Cash, cash equivalents and investments | $ | 1,643.1 | $ | 1,781.7 |
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) (BioMarin or the Company) today announced financial results for the second quarter ended June 30, 2018 . The financial results that follow represent a comparison of the second quarter of 2018 to the second quarter of 2017. Total revenues were $372.8 million for the quarter ended June 30, 2018 compared to $317.4 million for the quarter ended June 30, 2017 , an increase of 17%. GAAP Net Loss for the quarter ended June 30, 2018 was $16.8 million , or $0.09 loss per basic and diluted share compared to GAAP Net Loss of $36.8 million , or $0.21 loss per basic and diluted share for the quarter ended June 30, 2017 .
Net product sales for the second quarter of 2018 were $367.8 million , compared to $315.9 million in the second quarter of 2017. The increase in net product sales was attributed to the following:
The decrease in GAAP Net Loss was primarily due to the following:
Non-GAAP Income for the second quarter of 2018 was $19.9 million , compared to Non-GAAP Income of $26.6 million in the second quarter of 2017. The decrease in Non-GAAP income in the second quarter of 2018 is primarily attributed to higher R&D and SG&A expenses, partially offset by increased gross profit from revenues.
As of June 30, 2018 , BioMarin had cash, cash equivalents and investments totaling approximately $1.6 billion , as compared to $1.8 billion on December 31, 2017 . Our 0.75% senior subordinated convertible notes due 2018 are scheduled to mature in October 2018. Holders have the right to convert their notes at maturity, and with respect to any such conversions we have elected to settle in cash up to the principal amount of the notes, shares of our common stock in respect of conversion value in excess thereof, and cash in lieu of any fractional shares.
Commenting on second quarter results, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "In the quarter, BioMarin achieved numerous value-creating events on both the commercial and regulatory fronts. On May 24 we received standard FDA approval of Palynziq, an important new therapy that helps address a significant unmet need in adults with phenylketonuria (PKU) who have been unable to control their blood Phe levels with current treatment options. We are very happy with the pace of the initial commercial launch of Palynziq and look forward to providing an update on launch metrics in the third quarter of this year."
"In clinical development, we provided two years of clinical data with the 6e13 vg/kg dose of valoctocogene roxaparvovec gene therapy for severe Hemophilia A from the ongoing Phase 1/2 study in at the World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, Scotland . The updated data demonstrated the elimination of need for prophylaxis and no spontaneous bleeds in two years. In addition, we amended the protocol for the global GENEr8-1 (Phase 3) pivotal study to evaluate superiority compared to the current standard of care. The number of participants has been increased to 130 and we now anticipate completing enrollment during the first quarter of 2019."
Mr. Bienaimé continued, "With seven commercial products expected to generate approximately $1.5 billion in revenues this year, two potentially $1.0 billion plus late-stage clinical product opportunities, whose pivotal studies are expected to be fully enrolled later this year and in Q1 2019, I believe BioMarin's commercial prospects have never been better."
Updated August 2, 2018 Full-Year Financial Guidance ($ in millions, except %)
| Item | 2018 Guidance | August 2, 2018 | ||
| Total Revenues | $1,470 to $1,530 | Unchanged | ||
| Kuvan Net Product Revenues | $440 to $480 | Unchanged | ||
| Naglazyme Net Product Revenues | $325 to $355 | Unchanged | ||
| Vimizim Net Product Revenues | $460 to $500 | Unchanged | ||
| Brineura Net Product Revenues | $35 to $55 | Unchanged | ||
| Cost of Sales (% of Total Revenues) | 20.0% to 21.0% | Unchanged | ||
| Research and Development Expense | $645 to $685 | $680 to $710 | ||
| Selling, General and Admin. Expense | $575 to $615 | Unchanged | ||
| GAAP Net Loss | $(115) to $(165) | Unchanged | ||
| Non-GAAP Income * | $100 to $140 | Unchanged |
Key Program Highlights
Other Ongoing Clinical Development Programs:
BioMarin will host a conference call and webcast to discuss second quarter 2018 financial results today, Thursday, August 2, 2018 at 4:30 p.m. ET . This event can be accessed on the investor section of the BioMarin website at www.biomarin.com .
| U.S. / Canada Dial-in Number: 866.502.9859 | Replay Dial-in Number: 855.859.2056 |
| International Dial-in Number: 574.990.1362 | Replay International Dial-in Number: 404.537.3406 |
| Conference ID: 3364409 | Conference ID: 3364409 |
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The Company's portfolio consists of seven approved products and multiple clinical and pre-clinical product candidates. For additional information, please visit www.biomarin.com .
Forward-Looking Statements
BioMarin ® , Brineura ® , Firdapse ® , Kuvan ® , Naglazyme ® and Vimizim ® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Palynziq™ is our trademark. Aldurazyme ® is a registered trademark of BioMarin/Genzyme LLC.
| Contact: | ||
| Investors: | Media: | |
| Traci McCarty | Debra Charlesworth | |
| BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
| (415) 455-7558 | (415) 455-7451 |
| BIOMARIN PHARMACEUTICAL INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| June 30, 2018 and December 31, 2017 | ||||||||
| (In thousands of U.S. dollars, except share and per share amounts) | ||||||||
| June 30, 2018 (1) | December 31, 2017 (2) | |||||||
| ASSETS | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 427,411 | $ | 598,028 | ||||
| Short-term investments | 935,662 | 797,940 | ||||||
| Accounts receivable, net | 363,566 | 261,365 | ||||||
| Inventory | 473,356 | 475,775 | ||||||
| Other current assets | 80,072 | 74,036 | ||||||
| Total current assets | 2,280,067 | 2,207,144 | ||||||
| Noncurrent assets: | ||||||||
| Long-term investments | 279,988 | 385,785 | ||||||
| Property, plant and equipment, net | 900,480 | 896,700 | ||||||
| Intangible assets, net | 502,295 | 517,510 | ||||||
| Goodwill | 197,039 | 197,039 | ||||||
| Deferred tax assets | 425,380 | 399,095 | ||||||
| Other assets | 39,430 | 29,852 | ||||||
| Total assets | $ | 4,624,679 | $ | 4,633,125 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 358,732 | $ | 401,921 | ||||
| Short-term convertible debt, net | 369,752 | 360,949 | ||||||
| Short-term contingent acquisition consideration | 76,466 | 53,648 | ||||||
| Total current liabilities | 804,950 | 816,518 | ||||||
| Noncurrent liabilities: | ||||||||
| Long-term convertible debt, net | 821,871 | 813,521 | ||||||
| Long-term contingent acquisition consideration | 57,674 | 135,318 | ||||||
| Other long-term liabilities | 55,080 | 59,105 | ||||||
| Total liabilities | 1,739,575 | 1,824,462 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value: 500,000,000 shares authorized; 177,508,163 and 175,843,749 shares issued and outstanding, respectively. | 178 | 176 | ||||||
| Additional paid-in capital | 4,577,300 | 4,483,220 | ||||||
| Company common stock held by Nonqualified Deferred Compensation Plan | (13,390) | (14,224) | ||||||
| Accumulated other comprehensive loss | (1,129) | (22,961) | ||||||
| Accumulated deficit | (1,677,855) | (1,637,548) | ||||||
| Total stockholders' equity | 2,885,104 | 2,808,663 | ||||||
| Total liabilities and stockholders' equity | $ | 4,624,679 | $ | 4,633,125 |
| (1) | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers (ASC 606), using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. |
| (2) | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission on February 26, 2018. |
| BIOMARIN PHARMACEUTICAL INC. | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| Three and Six Months Ended June 30, 2018 and 2017 | ||||||||||||||||
| (In thousands of U.S. dollars, except per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2018 (1) | 2017 | 2018 (1) | 2017 | |||||||||||||
| REVENUES: | ||||||||||||||||
| Net product revenues | $ | 367,786 | $ | 315,926 | $ | 736,885 | $ | 618,116 | ||||||||
| Royalty and other revenues | 5,059 | 1,522 | 9,407 | 3,077 | ||||||||||||
| Total revenues | 372,845 | 317,448 | 746,292 | 621,193 | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Cost of sales | 79,019 | 56,305 | 161,352 | 106,311 | ||||||||||||
| Research and development | 175,582 | 143,039 | 359,530 | 288,042 | ||||||||||||
| Selling, general and administrative | 153,280 | 143,505 | 291,616 | 263,524 | ||||||||||||
| Intangible asset amortization and contingent consideration | 10,227 | 13,411 | 23,429 | 22,336 | ||||||||||||
| Gain on sale of intangible assets | (20,000) | — | (20,000) | — | ||||||||||||
| Total operating expenses | 398,108 | 356,260 | 815,927 | 680,213 | ||||||||||||
| LOSS FROM OPERATIONS | (25,263) | (38,812) | (69,635) | (59,020) | ||||||||||||
| Equity in the loss of BioMarin/Genzyme LLC | (107) | (220) | (39) | (743) | ||||||||||||
| Interest income | 5,569 | 2,983 | 10,803 | 6,055 | ||||||||||||
| Interest expense | (12,225) | (10,040) | (23,787) | (20,159) | ||||||||||||
| Other income, net | 2,849 | 543 | 2,677 | 4,015 | ||||||||||||
| LOSS BEFORE INCOME TAXES | (29,177) | (45,546) | (79,981) | (69,852) | ||||||||||||
| Benefit from income taxes | (12,385) | (8,713) | (19,040) | (16,729) | ||||||||||||
| NET LOSS | $ | (16,792) | $ | (36,833) | $ | (60,941) | $ | (53,123) | ||||||||
| NET LOSS PER SHARE, BASIC AND DILUTED | $ | (0.09) | $ | (0.21) | $ | (0.35) | $ | (0.31) | ||||||||
| Weighted average common shares outstanding, basic and dilutive | 176,873 | 174,374 | 176,405 | 173,547 |
Non-GAAP Information
The results presented in this press release for the three and six months ended June 30, 2018 and 2017 include both GAAP information and Non-GAAP information. As used in this release, Non-GAAP Income (Loss) is defined by the Company as GAAP Net Loss excluding net interest expense, provision for (benefit from) income taxes, depreciation expense, amortization expense, stock-based compensation expense, contingent consideration expense and, in certain periods, certain other specified items, as detailed below when applicable. In addition, BioMarin includes in this press release the effects of these adjustments on certain components of GAAP Net Loss for each of the periods presented. In this regard, Non-GAAP Income (Loss) and its components, including Non-GAAP Cost of Sales, Non-GAAP Research and Development expenses, Non-GAAP Selling, General and Administrative expense, Non-GAAP Intangible Asset Amortization and Contingent Consideration, Non-GAAP Gain on the Sale of Intangible Asset and Non-GAAP Benefit From Income Taxes are statement of operations line items prepared on the same basis as, and therefore components of, the overall Non-GAAP measures.
Non-GAAP Income (Loss) and its components are not meant to be considered in isolation, as a substitute for, or superior to comparable GAAP measures and should be read in conjunction with the consolidated financial information prepared in accordance with GAAP. Investors should note that the Non-GAAP information is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP measures; likewise, the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP measures. Because of the non-standardized definitions, the Non-GAAP measure as used by BioMarin in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following table presents the reconciliation of GAAP Net Loss to Non-GAAP Income:
| Reconciliation of GAAP Net Loss to Non-GAAP Income | |||||||||||||||||
| (In millions of U.S. dollars) | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| Three Months Ended | Six Months Ended | Year Ending | |||||||||||||||
| June 30, | June 30, | December 31, 2018 | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | Guidance | |||||||||||||
| GAAP Net Loss | $ | (16.8) | $ | (36.8) | $ | (60.9) | $ | (53.1) | $(115.0) - $(165.0) | ||||||||
| Interest expense, net | 6.7 | 7.0 | 13.0 | 14.1 | 25.0 - 35.0 | ||||||||||||
| Benefit from income taxes | (12.3) | (8.7) | (19.0) | (16.7) | (40.0) - 0.0 | ||||||||||||
| Depreciation expense | 13.5 | 11.7 | 29.5 | 23.7 | 50.0 - 60.0 | ||||||||||||
| Amortization expense | 7.5 | 7.6 | 15.1 | 15.1 | 30.0 | ||||||||||||
| Stock-based compensation expense | 38.6 | 40.0 | 75.2 | 70.7 | 150.0 - 170.0 | ||||||||||||
| Contingent consideration expense | 2.7 | 5.8 | 8.3 | 7.2 | 20.0 - 30.0 | ||||||||||||
| Gain on sale of intangible assets | (20.0) | — | (20.0) | — | (20.0) | ||||||||||||
| Non-GAAP Income | $ | 19.9 | $ | 26.6 | $ | 41.2 | $ | 61.0 | $100 - $140 |
The following reconciliation of the GAAP reported to the Non-GAAP information provides the details of the effects of the Non-GAAP adjustments on certain components of the Company's operating results for each of the periods presented.
| Reconciliation Of Certain GAAP Reported Information To Non-GAAP Information | |||||||||||||||||||||||||||||||
| (In millions of U.S. dollars) | |||||||||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||||||||
| Three Months Ended June 30. | |||||||||||||||||||||||||||||||
| 2018 | 2017 | ||||||||||||||||||||||||||||||
| Adjustments | Adjustments | ||||||||||||||||||||||||||||||
| GAAP Reported | Interest, Taxes, Depreciation and Amortization | Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non-GAAP | GAAP Reported | Interest, Taxes, Depreciation and Amortization | Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non-GAAP | ||||||||||||||||||||||||
| Cost of sales | $ | 79.1 | $ | — | $ | (3.3) | $ | 75.8 | $ | 56.3 | $ | — | $ | (2.5) | $ | 53.8 | |||||||||||||||
| Research and development | 175.6 | (7.9) | (15.5) | 152.2 | 143.0 | (6.2) | (14.6) | 122.2 | |||||||||||||||||||||||
| Selling, general and administrative | 153.3 | (5.6) | (19.8) | 127.9 | 143.5 | (5.5) | (22.9) | 115.1 | |||||||||||||||||||||||
| Intangible asset amortization and contingent consideration | 10.2 | (7.5) | (2.7) | — | 13.4 | (7.6) | (5.8) | — | |||||||||||||||||||||||
| Gain on sale of intangible assets | (20.0) | — | 20.0 | — | — | — | — | ||||||||||||||||||||||||
| Interest expense, net | (6.7) | 6.7 | — | — | (7.0) | 7.0 | — | — | |||||||||||||||||||||||
| Benefit from income taxes | (12.3) | 12.3 | — | — | (8.7) | 8.7 | — | — | |||||||||||||||||||||||
| GAAP Net Loss/Non-GAAP Income | (16.8) | 15.4 | 21.3 | 19.9 | (36.8) | 17.6 | 45.8 | 26.6 | |||||||||||||||||||||||
| Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| 2018 | 2017 | ||||||||||||||||||||||||||||||
| Adjustments | Adjustments | ||||||||||||||||||||||||||||||
| GAAP Reported | Interest, Taxes, Depreciation and Amortization | Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non-GAAP | GAAP Reported | Interest, Taxes, Depreciation and Amortization | Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non-GAAP | ||||||||||||||||||||||||
| Cost of sales | $ | 161.4 | $ | — | $ | (6.4) | $ | 155.0 | $ | 106.3 | $ | — | $ | (4.8) | $ | 101.5 | |||||||||||||||
| Research and development | 359.5 | (18.4) | (28.8) | 312.3 | 288.0 | (12.7) | (26.1) | 249.2 | |||||||||||||||||||||||
| Selling, general and administrative | 291.6 | (11.1) | (40.0) | 240.5 | 263.5 | (11.0) | (39.8) | 212.7 | |||||||||||||||||||||||
| Intangible asset amortization and contingent consideration | 23.4 | (15.1) | (8.3) | — | 22.3 | (15.1) | (7.2) | — | |||||||||||||||||||||||
| Gain on sale of intangible assets | (20.0) | — | 20.0 | — | — | — | — | — | |||||||||||||||||||||||
| Interest expense, net | (13.0) | 13.0 | — | — | (14.1) | 14.1 | — | — | |||||||||||||||||||||||
| Benefit from income taxes | (19.0) | 19.0 | — | — | (16.7) | 16.7 | — | — | |||||||||||||||||||||||
| GAAP Net Loss/Non-GAAP Income (Loss) | (60.9) | 38.6 | 63.5 | 41.2 | (53.1) | 36.2 | 77.9 | 61.0 |
SOURCE BioMarin Pharmaceutical Inc.