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Financial Highlights ($ in millions, except per share data, unaudited)
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||
2013 | 2012 | % Change | 2013 | 2012 | % Change | |
Total BioMarin Revenue | $ 146.9 | $ 131.9 | 11.4% | $ 548.5 | $ 500.7 | 9.5% |
Total BioMarin Revenue | ||||||
(excluding Aldurazyme Net Product Transfer Revenue) - non-GAAP | 148.5 | 131.2 | 13.2% | 553.4 | 498.9 | 10.9% |
Naglazyme Net Product Revenue | 68.7 | 63.0 | 9.0% | 271.2 | 257.0 | 5.5% |
Aldurazyme BioMarin Net Product Revenue | 25.9 | 24.6 | 5.3% | 83.6 | 82.2 | 1.7% |
Aldurazyme Royalty Revenue | ||||||
(excluding Net Product Transfer Revenue) - non-GAAP | 27.5 | 23.9 | 15.1% | 88.5 | 80.4 | 10.1% |
Kuvan Net Product Revenue | 45.3 | 40.0 | 13.3% | 167.4 | 143.1 | 17.0% |
Firdapse Net Product Revenue | 4.3 | 3.4 | 26.5% | 16.1 | 14.2 | 13.4% |
VIMIZIM | 0.1 | -- | 0.1 | -- | ||
Non-GAAP Net Loss | $ (15.8) | $ (15.5) | $ (40.4) | $ (11.6) | ||
Non-GAAP Net Loss per Share (basic) | $ (0.11) | $ (0.12) | $ (0.29) | $ (0.10) | ||
Non-GAAP Net Loss per Share (diluted) | $ (0.11) | $ (0.12) | $ (0.30) | $ (0.12) | ||
GAAP Net Loss | $ (62.0) | $ (53.0) | $ (176.4) | $ (114.3) | ||
GAAP Net Loss per Share (basic) | $ (0.43) | $ (0.43) | $ (1.28) | $ (0.95) | ||
GAAP Net Loss per Share (diluted) | $ (0.44) | $ (0.43) | $ (1.28) | $ (0.95) | ||
Cash, cash equivalents and investments * | $1,052.4 | $ 563.8 | 86.7% | |||
* The cash balance at the end of 2013 includes net proceeds of $696.4 million from the Convertible Debt offering in October 2013. |
SAN RAFAEL, Calif., Feb. 26, 2014 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced financial results for the fourth quarter and full year 2013. Non-GAAP net loss was $15.8 million ($0.11 per share, basic and diluted) for the fourth quarter of 2013, compared to non-GAAP net loss of $15.5 million ($0.12 per share, basic and diluted) for the fourth quarter of 2012. GAAP net loss was $62.0 million ($0.43 per share, basic and $0.44 per share, diluted) for the fourth quarter of 2013, compared to GAAP net loss of $53.0 million ($0.43 per share, basic and diluted) for the fourth quarter of 2012. The increased non-GAAP net loss and GAAP net loss for the fourth quarter of 2013 compared to the fourth quarter of 2012 was primarily due to increased research and development expenses, including costs associated with PEG PAL, BMN 673 and BMN 270, the Company's AAV-factor VIII gene therapy drug candidate for the treatment of hemophilia A, as well as increased selling, general and administrative expenses, including costs associated with VIMIZIM launch activities, partially offset by increased net product revenues.
Non-GAAP net loss was $40.4 million ($0.29 per share, basic and $0.30 per share, diluted) for the year ended December 31, 2013, compared to non-GAAP net loss of $11.6 million ($0.10 per share, basic and $0.12 per share, diluted) for the year ended December 31, 2012. GAAP net loss for the year ended December 31, 2013 was $176.4 million ($1.28 per share, basic and diluted), compared to GAAP net loss of $114.3 million ($0.95 per share, basic and diluted) for the year ended December 31, 2012. The increased non-GAAP net loss and GAAP net loss for the year ended December 31, 2013 compared to the year ended December 31, 2012 was primarily due to increased research and development expenses including costs associated with PEG PAL, BMN 673 and BMN 190 programs and increased selling, general and administrative expenses, including costs associated with VIMIZIM launch activities, partially offset by increased net product revenue.
As of December 31, 2013, BioMarin had cash, cash equivalents and investments totaling $1,052.4 million, as compared to $507.1 million on September 30, 2013.
"2013 was a pivotal year for BioMarin. Our growing commercial portfolio drove nearly $550 million in total revenue and our next significant value driver, VIMIZIM for the treatment of Morquio A syndrome, was approved by the FDA on February 14th," said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. "In addition, during the year we advanced several programs across our development pipeline. We initiated two Phase 3 programs, BMN 673 for the treatment of gBRCA breast cancer and PEG PAL for the treatment of phenylketonuria. Phase 2 testing with BMN 111 for the treatment of achondroplasia began, and we moved BMN 190 into Phase 1/2 for Batten Disease. We started 2014 with the selection of two new drug candidates, an AAV-factor VIII gene therapy vector, BMN 270, for the treatment of hemophilia A and BMN 250, an enzyme replacement therapy for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB) or Sanfilippo Syndrome Type B. I am very pleased with BioMarin's remarkable growth in 2013 across the commercial and development portfolios and expect the momentum to continue throughout 2014."
Net Product Revenue
Total Revenue Growth, excluding Aldurazyme Net Product Transfer Revenues (in millions) | ||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
2013 | 2012 | $ Change | % Change | 2013 | 2012 | $ Change | % Change | |
Naglazyme (1) | $ 68.7 | $ 63.0 | $ 5.7 | 9.0% | $ 271.2 | $ 257.0 | $ 14.2 | 5.5% |
Kuvan | 45.3 | 40.0 | 5.3 | 13.3% | 167.4 | 143.1 | 24.3 | 17.0% |
Firdapse | 4.3 | 3.4 | 0.9 | 26.5% | 16.1 | 14.2 | 1.9 | 13.4% |
Aldurazyme | 25.9 | 24.6 | 1.3 | 5.3% | 83.6 | 82.2 | 1.4 | 1.7% |
VIMIZIM | 0.1 | -- | 0.1 | 0.1 | -- | 0.1 | -- | |
Net product revenue | 144.3 | 131.0 | 13.3 | 10.2% | 538.4 | 496.5 | 41.9 | 8.4% |
Collaborative agreement revenue | 1.1 | 0.2 | 0.9 | 3.9 | 1.9 | 2.0 | ||
Royalty and license revenue | 1.5 | 0.7 | 0.8 | 6.2 | 2.3 | 3.9 | ||
Total BioMarin revenue - GAAP | 146.9 | 131.9 | 15.0 | 11.4% | 548.5 | 500.7 | 47.8 | 9.5% |
Less: Aldurazyme net product transfer revenue | (1.6) | 0.7 | (2.3) | (4.9) | 1.8 | (6.7) | ||
Total BioMarin revenues (excluding Aldurazyme net product transfer revenue) - Non-GAAP (2) | $ 148.5 | $ 131.2 | $ 17.3 | 13.2% | $ 553.4 | $ 498.9 | $ 54.5 | 10.9% |
Reconciliation of Aldurazyme Revenues (in millions) | ||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
2013 | 2012 | $ Change | % Change | 2013 | 2012 | $ Change | % Change | |
Aldurazyme revenue reported by Genzyme | $ 59.5 | $ 53.1 | $ 6.4 | 12.1% | $ 212.4 | $ 193.1 | $ 19.3 | 10.0% |
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
2013 | 2012 | $ Change | 2013 | 2012 | $ Change | |||
Aldurazyme Royalties due from Genzyme - Non-GAAP (2) | $ 27.5 | $ 23.9 | $ 3.6 | $ 88.5 | $ 80.4 | $ 8.1 | ||
Incremental net product transfer revenue (3) | (1.6) | 0.7 | (2.3) | (4.9) | 1.8 | (6.7) | ||
Total Aldurazyme net product revenue - GAAP | $ 25.9 | $ 24.6 | $ 1.3 | $ 83.6 | $ 82.2 | $ 1.4 | ||
(1) Naglazyme revenues experience quarterly fluctuations due to the timing of government ordering patterns in certain countries. For example, quarterly sales to Brazil have been between $11M-$17M for Q1 2012 through Q2 2013. In each of these quarters there has been a centralized Brazil Ministry of Health (MOH) order for more than 50% of the Brazil ordering. However, in Q3 2013 there was no large, centralized order from the Brazilian MOH. The Company does not believe these fluctuations reflect a change in underlying demand, simply the timing of the Brazil MOH order. In Q4 2013, the Company received a centralized order from the Brazilian MOH. | ||||||||
(2) BioMarin believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin's GAAP information because it provides additional information regarding the end-user demand for Aldurazyme. The Aldurazyme net product transfer revenue is the result of timing of deliveries to Genzyme Corp. and is therefore not representative of patient demand for the product. By providing information about both the GAAP and non-GAAP revenue measures, the Company believes that the additional information enhances investors' overall understanding of the Company's business and in particular allows for more consistent period to period evaluation of the revenue. | ||||||||
(3) To the extent units shipped to third party customers by Genzyme exceed BioMarin inventory transfers to Genzyme, BioMarin will record a decrease in net product revenue from the royalty payable to BioMarin for the amount of previously recognized product transfer revenue. If BioMarin inventory transfers exceed units shipped to third party customers by Genzyme, BioMarin will record incremental net product transfer revenue for the period. |
2014 Guidance
Revenue Guidance ($ in millions) | |
Item | 2014 Guidance |
Total BioMarin Revenues | $650 to $680 |
Naglazyme Net Product Revenue | $290 to $310 |
Kuvan Net Product Revenue | $180 to $200 |
VIMIZIM | $60 to $70 |
Selected Income Statement Guidance ($ in millions) | |
Item | 2014 Guidance |
Cost of Sales (% of Total Revenue) | 17.5% to 18.5% |
Selling, General and Admin. Expense | $265 to $285 |
Research and Development Expense | $500 to $530 |
GAAP Net Loss | $(255) to $(285) |
Non-GAAP Net Loss | $(100) to $(130) |
Anticipated Upcoming Milestones
1Q 2014: Initiation of Phase 2/3 trial with BMN 701 for the treatment of Pompe disease
2Q 2014: Potential EU approval of VIMIZIM for MPS IVA
2Q 2014: Potential EU launch of VIMIZIM for MPS IVA
Mid 2014: Enrollment completion of Phase 3 trial with PEG PAL for the treatment of phenylketonuria (PKU)
4Q 2014: Enrollment completion of Phase 1/2 trial with BMN 111 for the treatment of achondroplasia
4Q 2014: Results from pivotal Phase 3 trial with PEG PAL for the treatment of PKU
1Q 2015: Submission of PEG PAL BLA to the FDA for the treatment of PKU
1Q 2015: IND filing or equivalent for BMN 270 for the treatment of Hemophilia A
2Q 2015: Data on first three cohorts in Phase 1/2 with BMN 111 for the treatment of achondroplasia
1H 2015: Enrollment completion of Phase 2/3 trial with BMN 701 for the treatment of Pompe disease
2H 2015: Results from Phase 1/2 trial with BMN 190 for the treatment of Batten's disease
2H 2015: Enrollment completion of Phase 3 trial with BMN 673 for the treatment of mBC
2H 2015: IND filing or equivalent for BMN 250 for the treatment of MPS IIIB
Commercial and Regulatory Update on VIMIZIM for Mucopolysaccharidosis type IVA
Advanced Clinical Programs
Early-Stage Clinical Programs
Preclinical Programs
Non-GAAP Financial Information and Reconciliation
The results for the three months and year ended December 31, 2013 and December 31, 2012 are all determined in accordance with GAAP except for non-GAAP net loss which is determined on a non-GAAP basis. As used in this release, non-GAAP net loss is based on GAAP earnings before interest, taxes, depreciation and amortization (EBITDA) and further adjusted to also exclude certain non-cash stock compensation expense, non-cash contingent consideration expense and certain other nonrecurring material items (non-GAAP net loss).
The following table presents the reconciliation of GAAP to non-GAAP financial metrics:
Reconciliation of GAAP Net Loss to Non-GAAP Net Loss | |||||
(in millions) | |||||
(unaudited) | |||||
Three Months Ended December 31, |
Twelve Months Ended December 31, |
Year Ending December 31, |
|||
2013 | 2012 | 2013 | 2012 | 2014 Guidance | |
GAAP Net Loss | $ (62.0) | $ (53.0) | $ (176.4) | $ (114.3) | $(255) - $(285) |
Interest expense, net | 6.5 | 1.2 | 7.4 | 5.0 | 35.0 |
Provision for (benefit from) income taxes | 2.6 | 2.9 | (0.1) | (3.9) | (24.5) |
Depreciation expense | 6.4 | 6.6 | 25.4 | 27.5 | 36.0 |
Amortization expense | 2.6 | 2.6 | 11.5 | 17.3 | 10.5 |
EBITDA Loss | (43.9) | (39.7) | (132.2) | (68.4) | (198) - (228) |
Stock-based compensation expense | 22.7 | 12.1 | 64.4 | 48.0 | 83.0 |
Contingent consideration expense (1) | 4.6 | 12.1 | 14.4 | 8.8 | 15.0 |
Material non-recurring: | |||||
Debt conversion expense (2) | 0.8 | -- | 13.0 | -- | -- |
Non-GAAP Net Loss | $ (15.8) | $ (15.5) | $ (40.4) | $ (11.6) | $(100) - $(130) |
(1) Represents the expense associated with the change in the fair value of contingent acquisition consideration payable for the period, resulting from changes in estimated probabilities and timing of achieving certain developmental milestones. | |||||
(2) Represents debt conversion expense associated with the early conversion of a portion of our 2017 convertible notes in March, August and November 2013. |
BioMarin believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin's GAAP information because it provides additional information regarding the performance of BioMarin's core ongoing business, Naglazyme, Kuvan, Aldurazyme and Firdapse and development of its pipeline. By providing information about both the overall GAAP financial performance and the non-GAAP measures that focus on continuing operations, the Company believes that the additional information enhances investors' overall understanding of the Company's business and prospects for the future. Further, the Company uses both the GAAP and the non-GAAP results and expectations internally for its operating, budgeting and financial planning purposes.
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises five approved products and multiple clinical and pre-clinical product candidates. Approved products include VIMIZIM™ (elosulfase alfa) for MPS IVA; Naglazyme® (galsulfase) for MPS VI; Aldurazyme® (laronidase) for MPS I, a product which BioMarin developed through a 50/50 joint venture with Genzyme, a Sanofi Company; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany and Firdapse® (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include PEG PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase 3 clinical development for the treatment of PKU, BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase 3 clinical development for the treatment of germline BRCA breast cancer, BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase 1/2 clinical development for the treatment of Pompe disease, BMN 111, a modified C-natriuretic peptide, which is currently in Phase 1 clinical development for the treatment of achondroplasia, BMN 190, a recombinant human tripeptidyl peptidase-1 (rhTPP1) for the treatment of late-infantile neuronal ceroid lipofuscinosis (CLN2), a form of Batten Disease, which is currently in Phase 1, BMN 270, an AAV-factor VIII vector, for the treatment of hemophilia A and BMN 250, a novel fusion of alpha-N-acetyglucosaminidase (NAGLU) with a peptide derived from insulin-like growth factor 2 (IGF2), for the treatment of MPS IIIB. For additional information, please visit www.BMRN.com.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the expectations of revenue and sales related to Naglazyme, Kuvan, Firdapse, Aldurazyme and VIMIZIM; the financial performance of the BioMarin as a whole; the timing of BioMarin's clinical trials of PEG PAL, BMN 673, BMN 701, BMN 111, BMN 190, BMN 270, BMN 250 and other product candidates; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Kuvan, Firdapse, VIMIZIM and its product candidates; and actions by regulatory authorities. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: our success in the commercialization of VIMIZIM, Naglazyme, Kuvan, and Firdapse; Genzyme Corporation's success in continuing the commercialization of Aldurazyme; results and timing of current and planned preclinical studies and clinical trials, particularly with respect to PEG PAL, BMN 673, BMN 701, BMN 111 and BMN 190; our ability to successfully manufacture our products and product candidates; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products and particularly Aldurazyme, Naglazyme, Kuvan, VIMIZIM and Firdapse; actual sales of Aldurazyme, Naglazyme, Kuvan, VIMIZIM and Firdapse; Merck Serono's activities related to Kuvan; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2013 Annual Report on Form 10-K, and the factors contained in BioMarin's reports on Form 10-Q. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin®, Naglazyme®, Kuvan® and Firdapse™ are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. VIMIZIM™ is a trademark of BioMarin Pharmaceutical Inc., or its affiliates.
BIOMARIN PHARMACEUTICAL INC. | ||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
December 31, 2013 and December 31, 2012 | ||
(In thousands of U.S. dollars, except share and per share amounts) | ||
December 31, 2013 | December 31, 2012(1) | |
ASSETS | (unaudited) | |
Current assets: | ||
Cash and cash equivalents | $ 568,781 | $ 180,527 |
Short-term investments | 215,942 | 267,278 |
Accounts receivable, net (allowance for doubtful accounts: $529 and $348, respectively) | 117,822 | 109,066 |
Inventory | 162,605 | 128,695 |
Current deferred tax assets | 30,561 | 32,356 |
Other current assets | 41,707 | 25,509 |
Total current assets | 1,137,418 | 743,431 |
Noncurrent assets: | ||
Investment in BioMarin/Genzyme LLC | 816 | 1,080 |
Long-term investments | 267,700 | 115,993 |
Property, plant and equipment, net | 319,316 | 284,473 |
Intangible assets, net | 163,147 | 162,980 |
Goodwill | 54,258 | 51,543 |
Long-term deferred tax assets | 150,391 | 189,303 |
Other assets | 156,171 | 19,544 |
Total assets | $ 2,249,217 | $ 1,568,347 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Current liabilities: | ||
Accounts payable and accrued liabilities | $ 183,271 | $ 147,068 |
Convertible debt | -- | 23,365 |
Total current liabilities | 183,271 | 170,433 |
Noncurrent liabilities: | ||
Long-term convertible debt | 655,566 | 324,859 |
Long-term contingent acquisition consideration payable | 30,790 | 30,618 |
Other long-term liabilities | 38,549 | 26,674 |
Total liabilities | 908,176 | 552,584 |
Stockholders' equity: | ||
Common stock, $0.001 par value: 250,000,000 shares authorized at December 31, 2013 and 2012; 143,463,668 and 125,809,162 shares issued and outstanding at December 31, 2013 and 2012, respectively. | 144 | 126 |
Additional paid-in capital | 2,059,101 | 1,561,890 |
Company common stock held by Nonqualified Deferred Compensation Plan | (7,421) | (6,603) |
Accumulated other comprehensive income (loss) | 5,018 | (202) |
Accumulated deficit | (715,801) | (539,448) |
Total stockholders' equity | 1,341,041 | 1,015,763 |
Total liabilities and stockholders' equity | $ 2,249,217 | $ 1,568,347 |
(1) December 31, 2012 balances were derived from the audited consolidated financial statements. |
BIOMARIN PHARMACEUTICAL INC. | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Three and Twelve Months Ended December 31, 2013 and 2012 | ||||
(In thousands of U.S. dollars, except per share amounts) | ||||
(Unaudited) | ||||
Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||
2013 | 2012 | 2013 | 2012 | |
REVENUES: | ||||
Net product revenues | $ 144,286 | $ 130,957 | $ 538,360 | $ 496,497 |
Collaborative agreement revenues | 1,140 | 226 | 3,918 | 1,955 |
Royalty and license revenues | 1,447 | 755 | 6,207 | 2,271 |
Total revenues | 146,873 | 131,938 | 548,485 | 500,723 |
OPERATING EXPENSES: | ||||
Cost of sales (excludes amortization of certain acquired intangible assets) | 24,621 | 26,532 | 95,742 | 91,830 |
Research and development | 97,312 | 84,363 | 354,780 | 302,218 |
Selling, general and administrative | 71,809 | 55,049 | 235,356 | 198,173 |
Intangible asset amortization and contingent consideration | 5,441 | 12,898 | 18,614 | 18,717 |
Total operating expenses | 199,183 | 178,842 | 704,492 | 610,938 |
LOSS FROM OPERATIONS | (52,310) | (46,904) | (156,007) | (110,215) |
Equity in the loss of BioMarin/Genzyme LLC | (438) | (253) | (1,149) | (1,221) |
Interest income | 1,141 | 765 | 3,083 | 2,584 |
Interest expense | (7,593) | (1,930) | (10,447) | (7,639) |
Debt conversion expense | (813) | -- | (12,965) | -- |
Other income (expense) | 638 | (1,772) | 982 | (1,787) |
LOSS BEFORE INCOME TAXES | (59,375) | (50,094) | (176,503) | (118,278) |
Provision for (benefit from) income taxes | 2,615 | 2,918 | (150) | (3,931) |
NET LOSS | $ (61,990) | $ (53,012) | $ (176,353) | $ (114,347) |
NET LOSS PER SHARE, BASIC | $ (0.43) | $ (0.43) | $ (1.28) | $ (0.95) |
NET LOSS PER SHARE, DILUTED | $ (0.44) | $ (0.43) | $ (1.28) | $ (0.95) |
Weighted average common shares outstanding, basic | 142,659 | 124,575 | 137,755 | 120,271 |
Weighted average common shares outstanding, diluted | 142,852 | 124,575 | 137,755 | 120,271 |
STOCK-BASED COMPENSATION EXPENSE | ||||
Total stock-based compensation expense included in the Condensed Consolidated Statements of Operations is as follows (unaudited): | ||||
Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||
2013 | 2012 | 2013 | 2012 | |
Cost of sales | $ 1,197 | $ 1,355 | $ 4,860 | $ 4,890 |
Research and development | 8,942 | 5,385 | 27,763 | 20,736 |
Selling, general and administrative | 12,539 | 5,325 | 31,753 | 22,346 |
$ 22,678 | $ 12,065 | $ 64,376 | $ 47,972 |
CONTACT: Investors: Traci McCarty BioMarin Pharmaceutical Inc. (415) 455-7558 Media: Debra Charlesworth BioMarin Pharmaceutical Inc. (415) 455-7451