Full Press Release Details
SAN RAFAEL, Calif. , April 25, 2019 /PRNewswire/ --
| Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) | ||||||||||||
| Three Months Ended March 31, | ||||||||||||
| 2019 | 2018 | % Change | ||||||||||
| Total Revenues | $ | 400.7 | $ | 373.4 | 7% | |||||||
| Net Product Revenues Marketed by BioMarin (1) | 349.2 | 303.0 | 15% | |||||||||
| Vimizim Net Product Revenues | 125.8 | 117.1 | 7% | |||||||||
| Kuvan Net Product Revenues | 106.9 | 99.1 | 8% | |||||||||
| Naglazyme Net Product Revenues | 86.9 | 75.0 | 16% | |||||||||
| Palynziq Net Product Revenues | 12.3 | — | n/a | |||||||||
| Brineura Net Product Revenues | 12.2 | 6.9 | 77% | |||||||||
| Aldurazyme Net Product Revenues | 45.3 | 66.1 | (31)% | |||||||||
| GAAP Net Loss | $ | (56.5) | $ | (44.1) | ||||||||
| GAAP Net Loss per Share – Basic | $ | (0.32) | $ | (0.25) | ||||||||
| GAAP Net Loss per Share – Diluted | $ | (0.32) | $ | (0.26) | ||||||||
| Non-GAAP Income (2) | $ | 24.8 | $ | 21.3 | ||||||||
| March 31, | December 31, | |||||||||||
| 2019 | 2018 | |||||||||||
| Cash, cash equivalents and investments | $ | 1,214.9 | $ | 1,320.2 |
| (1) | Net Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Kuvan, Naglazyme, Palynziq, Brineura and Firdapse, each calculated in accordance with Generally Accepted Accounting Principles in the United States (U.S. GAAP). Genzyme Corporation (Genzyme) is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third-parties. Refer page 8 for a table showing Net Product Revenues by product, including Firdapse. |
| (2) | Non-GAAP Income is defined by the Company as reported GAAP Net Income, 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. Refer to Non-GAAP Information beginning on page 8 of this press release for a complete discussion of the Company's Non-GAAP financial information and reconciliations to the comparable information reported under U.S. GAAP. |
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) (BioMarin or the Company) today announced financial results for the first quarter ended March 31, 2019 .
Total Net Product Revenues for the first quarter 2019 increased to $394.5 million , compared to $369.1 million for the first quarter of 2018. Net Product Revenues Marketed by BioMarin increased to $349.2 million , compared to $303.0 million for the first quarter of 2018. The increase in Net Product Revenues Marketed by BioMarin was attributed to the following:
Aldurazyme Net Product Revenues decreased $20.8 million , or 31%, due to timing of shipments to Genzyme. Under the new revenue standards adopted in 2018, the Company records Aldurazyme Net Product Revenues when the product is released and control is transferred to Genzyme based on the estimated variable consideration payable it expects to earn when the product is sold through by Genzyme. Aldurazyme net product sales reported by Genzyme increased to $75.7 million , or up 20% in the first quarter of 2019, compared to $62.9 million the same period in 2018.
The increase in GAAP Net Loss for the first quarter of 2019, compared to the same period in 2018 was primarily due to the following:
Non-GAAP Income for the first quarter of 2019 increased $3.5 million , or 16%, to $24.8 million , compared to $21.3 million for the same period in 2018. The increase in Non-GAAP Income for the quarter was attributed to increased gross profit from sales partially offset by higher SG&A expenses as described above.
As of March 31, 2019 , BioMarin had cash, cash equivalents and investments totaling approximately $1.2 billion , as compared to $1.3 billion on December 31, 2018 .
Mr. Bienaimé continued, "We have a number of other exciting catalysts on the horizon including the potential approval and launch of Palynziq in Europe later this year. We have been thrilled with the pace of the U.S. launch, as we ended the first quarter with 414 patients on reimbursed Palynziq. Building on this success and as part of our strategy to increase our leadership in the PKU market, we anticipate filing an IND for BMN 307, our gene therapy product for PKU, in the second half of 2019. BMN 307 demonstrated lifetime normalization of Phe in a validated PKU mouse model, and as a result we believe it has the potential to be an important new treatment and market expander as part of our PKU franchise. Finally, we look forward with great anticipation to the results of our global Phase 3 program with vosoritide for the treatment of achondroplasia. Our ongoing Phase 2 study has so far demonstrated an average additional cumulative height gain of 5.7 centimeters over 42 months. Based on data observed to date, we are very encouraged that vosoritide could potentially be the first approved treatment option for children with achondroplasia."
2019 Full-Year Financial Guidance unchanged (in millions, except %)
| Item | 2019 Guidance | ||||
| Total Revenues | $1,680 | to | $1,750 | ||
| Vimizim Net Product Revenues | $530 | to | $570 | ||
| Kuvan Net Product Revenues | $420 | to | $460 | ||
| Naglazyme Net Product Revenues | $350 | to | $380 | ||
| Palynziq Net Product Revenues | $70 | to | $100 | ||
| Brineura Net Product Revenues | $55 | to | $75 | ||
| Cost of Sales (% of Total Revenues) | 20% | to | 21% | ||
| Research and Development Expense | $740 | to | $780 | ||
| Selling, General and Admin. Expense | $650 | to | $690 | ||
| GAAP Net Loss | $(45) | to | $(85) | ||
| Non-GAAP Income * | $130 | to | $170 |
Key Program Highlights
BioMarin will host a conference call and webcast to discuss first quarter 2019 financial results today, Thursday, April 25, 2019 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: 9996637 | Conference ID: 9996637 |
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 several commercial products and multiple clinical and pre-clinical product candidates for the treatment of various diseases. For additional information, please visit www.biomarin.com .
Forward-Looking Statements
BioMarin ® , Brineura ® , Firdapse ® , Kuvan ® , Naglazyme ® , Palynziq ® and Vimizim ® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. 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 | ||||||||
| March 31, 2019 and December 31, 2018 | ||||||||
| (In thousands of U.S. dollars, except share and per share amounts) | ||||||||
| March 31, 2019 (1) | December 31, 2018 (2) | |||||||
| ASSETS | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 364,369 | $ | 493,982 | ||||
| Short-term investments | 530,485 | 590,326 | ||||||
| Accounts receivable, net | 393,429 | 342,633 | ||||||
| Inventory | 534,696 | 530,871 | ||||||
| Other current assets | 93,876 | 98,403 | ||||||
| Total current assets | 1,916,855 | 2,056,215 | ||||||
| Noncurrent assets: | ||||||||
| Long-term investments | 320,000 | 235,864 | ||||||
| Property, plant and equipment, net | 951,890 | 948,682 | ||||||
| Intangible assets, net | 485,981 | 491,808 | ||||||
| Goodwill | 197,039 | 197,039 | ||||||
| Deferred tax assets | 467,333 | 460,952 | ||||||
| Other assets | 96,300 | 36,568 | ||||||
| Total assets | $ | 4,435,398 | $ | 4,427,128 | ||||
| LIABILITIES AND STOCKHOLDERS ' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 412,830 | $ | 437,290 | ||||
| Short-term contingent consideration | 88,156 | 85,951 | ||||||
| Total current liabilities | 500,986 | 523,241 | ||||||
| Noncurrent liabilities: | ||||||||
| Long-term convertible debt, net | 834,766 | 830,417 | ||||||
| Long-term contingent consideration | 48,461 | 46,883 | ||||||
| Other long-term liabilities | 114,558 | 58,647 | ||||||
| Total liabilities | 1,498,771 | 1,459,188 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value: 500,000,000 shares authorized; 179,033,104 and 178,252,954 shares issued and outstanding, respectively. | 179 | 178 | ||||||
| Additional paid-in capital | 4,682,900 | 4,669,926 | ||||||
| Company common stock held by Nonqualified Deferred Compensation Plan | (12,912) | (13,301) | ||||||
| Accumulated other comprehensive income | 19,794 | 5,271 | ||||||
| Accumulated deficit | (1,753,334) | (1,694,134) | ||||||
| Total stockholders' equity | 2,936,627 | 2,967,940 | ||||||
| Total liabilities and stockholders' equity | $ | 4,435,398 | $ | 4,427,128 |
| (1) | As of January 1, 2019, the Company adopted the requirements of Accounting Standards Codification 842, Leases , using the modified retrospective method as of the effective date, and as a result, Other Assets and Liabilities are not comparable to the prior periods presented. |
| (2) | December 31, 2018 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, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2018. |
| BIOMARIN PHARMACEUTICAL INC. | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
| Three Months Ended March 31, 2019 and 2018 | |||||||||
| (In thousands of U.S. dollars, except per share amounts) | |||||||||
| Three Months Ended March 31, | |||||||||
| 2019 | 2018 | ||||||||
| (unaudited) | (unaudited) | ||||||||
| REVENUES: | |||||||||
| Net product revenues | $ | 394,483 | $ | 369,099 | |||||
| Royalty and other revenues | 6,262 | 4,348 | |||||||
| Total net revenues | 400,745 | 373,447 | |||||||
| OPERATING EXPENSES: | |||||||||
| Cost of sales | 89,182 | 82,333 | |||||||
| Research and development | 183,591 | 183,948 | |||||||
| Selling, general and administrative | 162,158 | 138,336 | |||||||
| Intangible asset amortization and contingent consideration | 19,765 | 13,202 | |||||||
| Total operating expenses | 454,696 | 417,819 | |||||||
| LOSS FROM OPERATIONS | (53,951) | (44,372) | |||||||
| Equity in the income (loss) of BioMarin/Genzyme LLC | (185) | 68 | |||||||
| Interest income | 6,298 | 5,234 | |||||||
| Interest expense | (6,727) | (11,562) | |||||||
| Other income (expense), net | 1,608 | (172) | |||||||
| LOSS BEFORE INCOME TAXES | (52,957) | (50,804) | |||||||
| Provision for (benefit from) income taxes | 3,516 | (6,655) | |||||||
| NET LOSS | $ | (56,473) | $ | (44,149) | |||||
| NET LOSS PER SHARE, BASIC | $ | (0.32) | $ | (0.25) | |||||
| NET LOSS PER SHARE, DILUTED | $ | (0.32) | $ | (0.26) | |||||
| Weighted average common shares outstanding, basic | 178,271 | 175,932 | |||||||
| Weighted average common shares outstanding, diluted | 178,271 | 176,150 |
The following table presents the Net Product Revenues by Product:
| Net Product Revenues By Product | |||||||
| (In millions of U.S. dollars) | |||||||
| (unaudited) | |||||||
| Three Months Ended | |||||||
| March 31, | |||||||
| 2019 | 2018 | ||||||
| Brineura | $ | 12.2 | $ | 6.9 | |||
| Firdapse | 5.1 | 4.9 | |||||
| Kuvan | 106.9 | 99.1 | |||||
| Naglazyme | 86.9 | 75.0 | |||||
| Palynziq | 12.3 | — | |||||
| Vimizim | 125.8 | 117.1 | |||||
| Net Product Revenues Marketed by BioMarin | 349.2 | 303.0 | |||||
| Aldurazyme Net Product Revenues Marketed by Genzyme | 45.3 | 66.1 | |||||
| Total Net Product Revenues | $ | 394.5 | $ | 369.1 |
Non-GAAP Information
The results presented in this press release include both GAAP information and Non-GAAP information. As used in this release, Non-GAAP Income 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 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 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 | Guidance | |||||||||||||||
| March 31, | Year Ending | |||||||||||||||
| 2019 | 2018 | December 31, 2019 | ||||||||||||||
| GAAP Net Loss | $ | (56.5) | $ | (44.1) | $ | (45.0) | − | $ | (85.0) | |||||||
| Interest expense, net | 0.4 | 6.3 | — | − | 10.0 | |||||||||||
| Provision for (Benefit from) income taxes | 3.5 | (6.7) | (50.0) | − | (30.0) | |||||||||||
| Depreciation expense | 14.9 | 16.0 | 45.0 | − | 60.0 | |||||||||||
| Amortization expense | 7.5 | 7.6 | 40.0 | − | 55.0 | |||||||||||
| Stock-based compensation expense | 42.7 | 36.6 | 150.0 | − | 175.0 | |||||||||||
| Contingent consideration expense | 12.3 | 5.6 | 20.0 | − | 30.0 | |||||||||||
| Gain on sale of intangible assets | — | — | (30.0) | − | (45.0) | |||||||||||
| Non-GAAP Income | $ | 24.8 | $ | 21.3 | $ | 130.0 | − | $ | 170.0 |
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 March 31, | |||||||||||||||||||||||||||||||
| 2019 | 2018 | ||||||||||||||||||||||||||||||
| 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 | $ | 89.2 | $ | — | $ | (4.8) | $ | 84.4 | $ | 82.3 | $ | — | $ | (3.1) | $ | 79.2 | |||||||||||||||
| Research and development | 183.6 | (9.3) | (13.8) | 160.5 | 183.9 | (10.5) | (13.3) | 160.1 | |||||||||||||||||||||||
| Selling, general and administrative | 162.2 | (5.6) | (24.1) | 132.5 | 138.3 | (5.5) | (20.2) | 112.6 | |||||||||||||||||||||||
| Intangible asset amortization and contingent consideration | 19.8 | (7.5) | (12.3) | — | 13.2 | (7.6) | (5.6) | — | |||||||||||||||||||||||
| Interest expense, net | (0.4) | 0.4 | — | — | (6.3) | 6.3 | — | — | |||||||||||||||||||||||
| Provision for (Benefit from) income taxes | 3.5 | (3.5) | — | — | (6.7) | 6.7 | — | — | |||||||||||||||||||||||
| GAAP Net Loss/ Non-GAAP Income | (56.5) | 26.3 | $ | 55.0 | 24.8 | (44.1) | 23.2 | 42.2 | 21.3 |
SOURCE BioMarin Pharmaceutical Inc.