Le Lézard
Classified in: Health, Science and technology, Business
Subjects: ERN, ERP

BioMarin Reports Record Financial Results for the Fourth Quarter and Full-year 2023 and Provides Financial Guidance for 2024


Total FY'23 Revenues of $2.42 Billion (+15% Y/Y and +20% Y/Y at Constant Currency); GAAP Diluted Earnings per Share of $0.87 (+16% Y/Y) and Non-GAAP Diluted Earnings per Share of $2.08 (+36% Y/Y)

VOXZOGO® Net Revenues of $146 Million in Q4'23 (+118% Q/Q) and $470 Million for FY'23 (+178% Y/Y)

BioMarin's 2024 Financial Outlook Reflects Anticipated Double-digit Total Revenue Growth, Significant Non-GAAP Operating Margin Expansion, and Non-GAAP Earnings Per Share Growing Faster than Revenues

Conference Call and Webcast Scheduled Today at 4:30 p.m. ET

SAN RAFAEL, Calif., Feb. 22, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced financial results for the fourth quarter and full year ended December 31, 2023.

"Strong financial results in 2023 were driven by global demand for VOXZOGO, the only approved treatment for children with achondroplasia, and contributions from our established enzyme products. VOXZOGO revenues grew 18% over the prior quarter and were positively impacted by an increase in prescriptions for children in the United States under the age of 5, following the Food and Drug Administration's (FDA) October approval of VOXZOGO for children of all ages with open growth plates," said Alexander Hardy, President and Chief Executive Officer of BioMarin. "Looking ahead in 2024, our full-year financial guidance reflects our focus on value creation through achievement of four strategic priorities outlined earlier this year. We intend to maximize the VOXZOGO opportunity, continue to build-out global access channels for ROCTAVIAN, judiciously prioritize the most potentially impactful R&D candidates, and drive operational excellence and cost optimization with the goal of delivering growth, efficiency and profitability."

Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)



Three Months Ended

December 31,


Twelve Months Ended

December 31,


2023


2022


% Change


2023


2022


% Change













Total Revenues

$        646.2


$        537.5


20 %


$     2,419.2


$     2,096.0


15 %













Total Enzyme Product Revenues (1)

$        448.0


$        405.1


11 %


$     1,718.3


$     1,645.3


4 %













VIMIZIM® Net Product Revenues

$        175.6


$        152.1


15 %


$        701.0


$        663.8


6 %

VOXZOGO Net Product Revenues

$        145.7


$          66.8


118 %


$        469.9


$        169.1


178 %

NAGLAZYME® Net Product Revenues

$          98.3


$        100.5


(2) %


$        420.3


$        443.8


(5) %

PALYNZIQ® Net Product Revenues

$          87.8


$          72.3


21 %


$        303.9


$        255.0


19 %

BRINEURA® Net Product Revenues

$          43.6


$          42.6


2 %


$        161.9


$        154.3


5 %

ALDURAZYME® Net Product Revenues

$          42.7


$          37.6


14 %


$        131.2


$        128.4


2 %

KUVAN® Net Product Revenues

$          36.7


$          53.6


(32) %


$        180.8


$        227.6


(21) %

ROCTAVIAN Net Product Revenues

$            2.7


$              ?


nm


$            3.5


$              ?


nm













GAAP Net Income (Loss) (2)

$          20.4


$           (0.2)




$        167.6


$        141.6



Non-GAAP Income (3)

$          94.9


$          63.1




$        405.4


$        290.8



GAAP Diluted Earnings (Loss) per Share (EPS)

$          0.11


$        (0.00)




$          0.87


$          0.75



Non-GAAP Diluted EPS (4)

$          0.49


$          0.33




$          2.08


$          1.53



 


December 31,
2023


December 31,
2022

Total cash, cash equivalents & investments

$               1,684.9


$               1,625.4

 

(1)

Enzyme Products include ALDURAZYME, BRINEURA, NAGLAZYME, PALYNZIQ, and VIMIZIM.



(2)

GAAP Net Income in the twelve months ended December 31, 2022 included a $89.0 million gain, net of taxes, related to the sale of the Rare Pediatric Disease Priority Review Voucher (PRV) the company received from the U.S. Food and Drug Administration (FDA) in connection with U.S. approval of VOXZOGO.



(3)

Non-GAAP Income is defined by the company as reported GAAP Net Income (Loss), excluding amortization expense, stock-based compensation expense, contingent consideration, and, in certain periods, certain other specified items. The company also includes a Non-GAAP adjustment for the estimated income tax impact of reconciling items. Refer to Non-GAAP Information beginning on page 9 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.



(4)

Non-GAAP Diluted EPS is defined by the company as Non-GAAP Income divided by Non-GAAP diluted weighted-average shares outstanding. Non-GAAP weighted-average diluted shares outstanding is defined by the company as GAAP weighted-average diluted shares outstanding, adjusted to include any common shares issuable under the company's equity plans and convertible debt in periods when they are dilutive under Non-GAAP.



nm

 Not meaningful

Financial Highlights:

2024 Strategic Priorities

In January, BioMarin management outlined key priorities focused on value creation through accelerating growth, optimizing efficiencies and driving operational excellence. For 2024, the company plans to provide material updates across the business, both scientific and financial, according to these strategic priorities:

Accelerate and maximize the VOXZOGO opportunity

Establish ROCTAVIAN opportunity

Focus R&D on the most productive assets

Accelerate EPS growth and expand margins

2024 Full-Year Financial Guidance

BioMarin does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the company is unable to predict with reasonable certainty the financial impact of changes resulting from our strategic portfolio and business operating model reviews; potential future asset impairments; gains and losses on investments; and other unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. As such, any reconciliations provided would imply a degree of precision that could be confusing or misleading to investors.

Item


2024 Guidance (in millions, except % and EPS amounts)

Total Revenues


$2,700


to


$2,800

Non-GAAP Operating Margin % (1)


23 %


to


24 %

Non-GAAP Diluted EPS (2)


$2.60


to


$2.80



(1)

Non-GAAP Operating Margin percentage is defined by the company as GAAP Income from Operations, excluding amortization of intangible assets, stock based compensation expense and certain specified items divided by Total Revenues.



(2)

Non-GAAP Diluted EPS guidance assumes approximately 200 million weighted-average diluted shares outstanding.

 

BioMarin will host a conference call and webcast to discuss fourth quarter and full year 2023 financial results and full-year 2024 financial guidance today, Thursday, February 22, 2024, at 4:30 p.m. ET. This event can be accessed through this link or on the investor section of the BioMarin website at www.biomarin.com.

U.S./Canada Dial-in Number: 888-330-3073

Replay Dial-in Number: 800-770-2030

International Dial-in Number:  646-960-0683

Replay International Dial-in Number: 647-362-9199

No Conference ID:  1816377

Conference ID: 1816377

 

About BioMarin

Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of genetic conditions. BioMarin's robust research and development capabilities have resulted in multiple innovative commercial therapies for patients with rare genetic disorders. The company's distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical, and pre-clinical candidates that address a significant unmet medical need, have well-understood biology, and provide an opportunity to be first-to-market or offer a substantial benefit over existing treatment options. For additional information, please visit www.biomarin.com.

Forward-Looking Statements

This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including, without limitation, statements about: the expectations of Total Revenues, Non-GAAP Operating Margin percentage, and Non-GAAP Diluted EPS for the full-year 2024; cash flows from operating activities; BioMarin's plans to reduce operating expenses and expand margins; BioMarin's focus on its strategic priorities and the anticipated benefits from the same; the timing of orders for commercial products; the timing of BioMarin's clinical development and commercial prospects, including announcements of data from clinical studies and trials; the clinical development and commercialization of BioMarin's product candidates and commercial products, including (i) the potential to leverage VOXZOGO in conditions beyond achondroplasia, such as hypochondroplasia as well as idiopathic short stature and other genetic short stature pathway conditions, and (ii) the product expansion opportunities for ROCTAVIAN, including results from any related clinical studies; the commercialization of BioMarin's products, including (i) the anticipated start and growth of commercial sales of VOXZOGO in additional countries, and (ii) the commercialization of ROCTAVIAN for the treatment of severe hemophilia A in the U.S. and Europe; the expected benefits and availability of BioMarin's product candidates; and potential growth opportunities and trends, including that BioMarin expects accelerated growth of VOXZOGO revenues as the product launch continues in future quarters and that BioMarin expects growth of ROCTAVIAN revenues as the product's access is expanded in Europe and the U.S.

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: BioMarin's success in the commercialization of its commercial products, impacts of macroeconomic and other external factors on BioMarin's operations; results and timing of current and planned preclinical studies and clinical trials and the release of data from those trials; BioMarin's ability to successfully manufacture its commercial products and product candidates; the content and timing of decisions by the FDA, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products; actual sales of BioMarin's commercial products; the introduction of generic versions of BioMarin's commercial products, in particular generic versions of KUVAN; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 as such factors may be updated by any subsequent reports. 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®, BRINEURA®, KUVAN®, NAGLAZYME®, PALYNZIQ®, VIMIZIM® and VOXZOGO® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. ROCTAVIAN® is a trademark of BioMarin Pharmaceutical Inc., with registration in Europe and pending in the U.S. ALDURAZYME® is a registered trademark of BioMarin/Genzyme LLC. All other brand names and service marks, trademarks and other trade names appearing in this release are the property of their respective owners.

Contact:



Investors:


Media:

Traci McCarty


Marni Kottle

BioMarin Pharmaceutical Inc.


BioMarin Pharmaceutical Inc.

(415) 455-7558


(650) 374-2803

 

BIOMARIN PHARMACEUTICAL INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

December 31, 2023 and December 31, 2022

(In thousands of U.S. dollars, except per share amounts)



December 31, 2023


December 31, 2022 ?¹?

ASSETS

(unaudited)



Current assets:




Cash and cash equivalents

$                       755,127


$                       724,531

Short-term investments

318,683


567,006

Accounts receivable, net

633,704


461,316

Inventory

1,107,183


894,083

Other current assets

141,391


104,521

Total current assets

2,956,088


2,751,457

Noncurrent assets:




Long-term investments

611,135


333,835

Property, plant and equipment, net

1,066,133


1,073,366

Intangible assets, net

294,701


338,569

Goodwill

196,199


196,199

Deferred tax assets

1,545,809


1,505,412

Other assets

171,538


176,236

Total assets

$                    6,841,603


$                    6,375,074

LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable and accrued liabilities

$                       683,147


$                       572,959

Short-term convertible debt, net

493,877


?

Short-term contingent consideration

?


15,925

Total current liabilities

1,177,024


588,884

Noncurrent liabilities:




Long-term convertible debt, net

593,095


1,083,019

Other long-term liabilities

119,935


100,015

Total liabilities

1,890,054


1,771,918

Stockholders' equity:




Common stock, $0.001 par value: 500,000,000 shares authorized; 188,598,154 and 186,250,719 shares issued and outstanding, respectively

189


186

Additional paid-in capital

5,611,562


5,404,895

Company common stock held by the Nonqualified Deferred Compensation Plan

(9,860)


(8,859)

Accumulated other comprehensive loss

(28,788)


(3,867)

Accumulated deficit

(621,554)


(789,199)

Total stockholders' equity

4,951,549


4,603,156

Total liabilities and stockholders' equity

$                    6,841,603


$                    6,375,074





(1)

December 31, 2022 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, 2022, filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2023.

 

BIOMARIN PHARMACEUTICAL INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Three and Twelve Months Ended December 31, 2023 and 2022

(In thousands of U.S. dollars, except per share amounts)



Three Months Ended

December 31,


Twelve Months Ended

December 31,


2023


2022


2023


2022


(unaudited)


(unaudited)


(unaudited)



REVENUES:








Net product revenues

$            633,148


$            525,492


$         2,372,538


$         2,042,025

Royalty and other revenues

13,059


12,046


46,688


54,014

Total revenues

646,207


537,538


2,419,226


2,096,039

OPERATING EXPENSES:








Cost of sales

135,478


127,290


514,854


483,669

Research and development

206,250


172,751


746,773


649,606

Selling, general and administrative

275,024


245,739


937,291


854,009

Intangible asset amortization and contingent consideration

15,236


16,258


62,211


67,193

Gain on sale of nonfinancial assets, net

?


?


?


(108,000)

Total operating expenses

631,988


562,038


2,261,129


1,946,477

INCOME (LOSS) FROM OPERATIONS

14,219


(24,500)


158,097


149,562









Interest income

18,044


8,710


58,339


18,034

Interest expense

(6,098)


(3,626)


(17,335)


(15,970)

Other income (expense), net

(6,838)


1,858


(10,538)


(2,050)

INCOME (LOSS) BEFORE INCOME TAXES

19,327


(17,558)


188,563


149,576

Provision for (benefit from) income taxes

(1,048)


(17,309)


20,918


8,015

NET INCOME (LOSS)

$             20,375


$                 (249)


$            167,645


$            141,561

EARNINGS (LOSS) PER SHARE, BASIC

$                 0.11


$                (0.00)


$                 0.89


$                 0.76

EARNINGS (LOSS) PER SHARE, DILUTED

$                 0.11


$                (0.00)


$                 0.87


$                 0.75

Weighted average common shares outstanding, basic

188,479


186,028


187,834


185,266

Weighted average common shares outstanding, diluted

191,838


186,028


191,595


188,963

 

BIOMARIN PHARMACEUTICAL INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Twelve Months Ended December 31, 2023 and 2022

(In thousands of U.S. dollars)



Twelve Months Ended December 31,


2023


2022


(unaudited)



CASH FLOWS FROM OPERATING ACTIVITIES:




Net income

$               167,645


$               141,561

Adjustments to reconcile net income to net cash used in operating activities:




Depreciation and amortization

104,386


101,969

Non-cash interest expense

4,188


4,117

Amortization of premium (accretion of discount) on investments

(9,228)


3,043

Stock-based compensation

207,099


196,308

Gain on sale of nonfinancial assets, net

?


(108,000)

Impairment of assets

38,608


?

Deferred income taxes

(44,981)


(52,087)

Unrealized foreign exchange loss (gain)

28,446


(14,287)

Non-cash changes in the fair value of contingent consideration

?


1,704

Other

(365)


(2,043)

Changes in operating assets and liabilities:




Accounts receivable, net

(190,435)


(82,033)

Inventory

(157,058)


(68,264)

Other current assets

(50,335)


7,822

Other assets

(31,149)


(19,859)

Accounts payable and other short-term liabilities

68,853


59,018

Other long-term liabilities

23,585


6,933

Net cash provided by operating activities

159,259


175,902

CASH FLOWS FROM INVESTING ACTIVITIES:




Purchases of property, plant and equipment

(96,691)


(120,959)

Maturities and sales of investments

864,863


619,995

Purchases of investments

(868,496)


(611,809)

Proceeds from sale of nonfinancial assets

?


103,325

Purchase of intangible assets

(10,920)


(10,581)

Net cash used in investing activities

(111,244)


(20,029)

CASH FLOWS FROM FINANCING ACTIVITIES:




Proceeds from exercises of awards under equity incentive plans

69,353


69,333

Taxes paid related to net share settlement of equity awards

(76,319)


(54,283)

Payments of contingent consideration

(9,475)


(31,095)

Principal repayments of financing leases

(2,286)


(2,605)

Net cash used in financing activities

(18,727)


(18,650)

Effect of exchange rate changes on cash

1,308


32

NET INCREASE IN CASH AND CASH EQUIVALENTS

30,596


137,255

Cash and cash equivalents:




Beginning of period

$               724,531


$               587,276

End of period

$               755,127


$               724,531

Non-GAAP Information

The results presented in this press release include both GAAP information and Non-GAAP information. Non-GAAP Income is defined by the company as GAAP Net Income (Loss) excluding amortization of intangible assets, stock-based compensation expense, contingent consideration expense, and, in certain periods, certain other specified items, as detailed below when applicable. Non-GAAP Operating Margin percentage is defined by the company as GAAP Income from Operations, excluding amortization of intangible assets, stock based compensation expense, contingent consideration expense, and, in certain periods, certain other specified items, divided by Total Revenues. The company also includes a Non-GAAP adjustment for the estimated tax impact of the reconciling items. Non-GAAP Diluted EPS is defined by the company as Non-GAAP Income divided by Non-GAAP diluted shares outstanding. The company's presentation of percentage changes in total revenues at constant currency rates, which is computed using current period local currency sales at the prior period's foreign exchange rates, is also a Non-GAAP financial measure. This measure provides information about growth (or declines) in the company's total revenue as if foreign currency exchange rates had not changed between the prior period and the current period.

BioMarin regularly uses both GAAP and Non-GAAP results and expectations internally to assess its financial operating performance and evaluate key business decisions related to its principal business activities: the discovery, development, manufacture, marketing and sale of innovative biologic therapies. Because Non-GAAP Income, Non-GAAP Operating Margin percentage, Non-GAAP Diluted EPS, Non-GAAP Diluted Shares and constant currency are important internal measurements for BioMarin, the company believes that providing this information in conjunction with BioMarin's GAAP information enhances investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance, and to identify operating trends in the company's principal business. BioMarin also uses Non-GAAP Income internally to understand, manage and evaluate its business and to make operating decisions, and compensation of executives is based in part on this measure.

Non-GAAP Income and its components are not meant to be considered in isolation or 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 financial 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 financial measures; likewise, the company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. Because of the non-standardized definitions, the Non-GAAP financial 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 tables present the reconciliation of GAAP reported to Non-GAAP adjusted financial information:

Reconciliation of GAAP Reported Net Income (Loss) to Non-GAAP Income(1)

(In millions of U.S. dollars)

(unaudited)



Three Months Ended

December 31,


Twelve Months Ended

December 31,


2023


2022


2023


2022









GAAP Reported Net Income (Loss)

$           20.4


$            (0.2)


$         167.6


$         141.6

Adjustments








Stock-based compensation expense - COS

4.5


4.3


17.6


17.7

Stock-based compensation expense - R&D

16.3


13.8


65.7


61.7

Stock-based compensation expense - SG&A

34.0


28.7


123.8


116.9

Amortization of intangible assets

15.2


15.7


62.2


62.8

Contingent consideration

?


0.6


?


4.4

Gain on sale of non-financial assets (2)

?


?


?


(108.0)

Severance and employee termination benefits (3)

?


18.2


(0.5)


23.0

Asset impairments (4)

14.0


?


14.0


?

Loss on investments (5)

11.9


?


24.5


?

Income tax effect of adjustments

(21.4)


(18.0)


(69.5)


(29.3)

Non-GAAP Income

$           94.9


$           63.1


$         405.4


$         290.8

 

Reconciliation of Certain GAAP Reported Information to Non-GAAP Information(1)

(in millions, except per share data)

(unaudited)



Three Months Ended

December 31,


Twelve Months Ended

December 31,


2023


2022


2023


2022









GAAP Diluted EPS

$           0.11


$          (0.00)


$           0.87


$           0.75

Adjustments








Stock-based compensation expense

0.27


0.24


1.04


1.02

Amortization of intangible assets

0.08


0.08


0.31


0.33

Contingent consideration

?


?


?


0.02

Gain on sale of non-financial assets (2)

?


?


?


(0.56)

Severance and employee termination benefits (3)

?


0.09


?


0.12

Asset impairments (4)

0.07


?


0.07


?

Loss on investments (5)

0.06


?


0.12


?

Income tax effect of adjustments

(0.10)


(0.09)


(0.33)


(0.15)

Non-GAAP Diluted EPS

$           0.49


$           0.33


$           2.08


$           1.53



(1)

Certain amounts may not sum or recalculate due to rounding.



(2)

Represents the net gain in the first quarter of 2022 on the sale to a third party of the PRV the company received from the FDA in connection with the U.S. approval of VOXZOGO.



(3)

Represents severance and employee termination benefit charges and subsequent adjustments included in SG&A related to the company's organizational redesign announced in the fourth quarter of 2022.



(4)

Represents the write-off of capitalized tooling and fixed assets in SG&A associated with the company's decision to cease development of the first generation VOXZOGO pen device in the fourth quarter of 2023.



(5)

Represents the impairment losses on an investment in non-marketable equity securities and a convertible note recorded in Other income (expense), net in the first and fourth quarter of 2023, respectively.

 


Three Months Ended

December 31,


Twelve Months Ended

December 31,


2023


2022


2023


2022









GAAP Weighted-Average Dilutive Shares Outstanding

191.8


186.0


191.6


189.0

Adjustments








Common stock issuable under the company's equity plans

?


4.1


?


?

Common stock issuable under company's convertible debt (1)

8.4


4.0


8.4


4.0

Non-GAAP Weighted-Average Dilutive Shares Outstanding

200.2


194.1


200.0


193.0



(1)

Common stock issuable under the company's convertible debt was excluded from the computation of GAAP Weighted-Average Dilutive Shares Outstanding when they were anti-dilutive. If converted, the company would issue 4.0 million shares under the convertible notes due in 2024 and 4.4 million shares under the convertible notes due in 2027.

 

SOURCE BioMarin Pharmaceutical Inc.


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Askable, the on-demand research and insight delivery platform, has closed a AU$22 million Series A funding round led by Airtree Ventures. With a mission to exponentially improve products through user insight, Askable connects enterprises with the...



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