Le Lézard
Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: ERN, ERP

BioMarin Announces Record Revenues in Second Quarter 2022; Increases Full-year 2022 Top and Bottom-line Guidance


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


Three Months Ended

June 30,


Six Months Ended

June 30,


2022


2021


% Change


2022


2021


% Change













Total Revenues

$       533.8


$       501.7


6 %


$    1,053.2


$       987.7


7 %













Net Product Revenues Marketed by BioMarin (1)

$       480.4


$       458.6


5 %


$       961.5


$       876.3


10 %













Vimizim Net Product Revenues

$       173.3


$       171.7


1 %


$       356.4


$       329.9


8 %

Naglazyme Net Product Revenues

$       115.8


$       118.8


(3) %


$       243.8


$       226.1


8 %

Palynziq Net Product Revenues

$         61.6


$         59.0


4 %


$       116.5


$       113.0


3 %

Kuvan Net Product Revenues

$         57.6


$         78.8


(27) %


$       116.9


$       149.6


(22) %

Brineura Net Product Revenues

$         37.7


$         30.3


24 %


$         73.9


$         57.7


28 %

Voxzogo Net Product Revenues

$         34.4


$             ?


n/a


$         54.0


$             ?


n/a













Aldurazyme Net Product Revenues

$         37.3


$         28.1


33 %


$         61.7


$         78.1


(21) %













GAAP Net Income

$         27.7


$         12.9




$       148.5


$         30.3



GAAP Net Income per Share ? Basic

$         0.15


$         0.07




$         0.80


$         0.17



GAAP Net Income per Share ? Diluted

$         0.15


$         0.07




$         0.79


$         0.16



Non-GAAP Income (2)

$       109.4


$         97.8




$       214.6


$       202.1



 


June 30,
2022


December 31,
2021

Total cash, cash equivalents & investments

$               1,522.3


$               1,521.7

 

(1)

Net Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Naglazyme, Palynziq, Kuvan, Brineura and Voxzogo for the three and six months ended June 30, 2022 and 2021, each calculated in accordance with Generally Accepted Accounting Principles in the United States (U.S. GAAP). Sanofi is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties.



(2)

Non-GAAP Income is defined by the Company as reported GAAP Net Income/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. 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.

 

SAN RAFAEL, Calif., Aug. 3, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) today announced financial results for the second quarter ended June 30, 2022.

BioMarin Announces Record Revenues in Second Quarter 2022; Increases Full-year 2022 Top and Bottom-line Guidance

 "Continued strong growth of VOXZOGO and solid contributions from our other franchises drove record revenues exceeding $1 billion in the first half of the year, leading us to increase our full-year 2022 top and bottom-line guidance," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "We also achieved many other significant milestones in the second quarter, including the CHMP's positive opinion for conditional marketing authorization of Roctavian, the first gene therapy to be recommended for approval in Europe for hemophilia A. Assuming a positive decision from the European Commission, BioMarin's commercial organization is ready to launch Roctavian in Europe in the third quarter. Based on the updated multi-year hemostatic efficacy observed to date following treatment with a single intravenous administration of Roctavian, we are on-track to resubmit the BLA in the U.S. to the FDA this September."

Mr. Bienaimé added, "In addition to continued robust demand for Voxzogo throughout the United States and Europe, underscored by today's significant increase in full-year 2022 guidance for Voxzogo net product revenues to between $130 million and $160 million, we were thrilled to receive commercial approval in both Japan and Australia in the quarter. As we said previously, in 2022 we expect to return to double-digit revenue growth and profitability, and we are tracking to plan as demonstrated by record revenues in both the first and second quarters of this year."

Financial Highlights:

New Product Launches and Anticipated Approvals (Voxzogo and Roctavian)

Mid-stage Product Life Cycle Expansion Opportunities (Voxzogo and Roctavian)

Earlier-stage Development Portfolio (BMN 255, BMN 331, BMN 351, BMN 349, BMN 293 (DiNA-001))

2022 Full-Year Financial Guidance (in millions, except %)

Item


Provided April 27, 2022


Revised August 3, 2022

Total Revenues


$2,050


to


$2,150


$2,060


to


$2,160

Vimizim Net Product Revenues


$650


to


$700


$655


to


$700

Naglazyme Net Product Revenues


$400


to


$440


$415


to


$450

Palynziq Net Product Revenues


$280


to


$310


$250


to


$275

Kuvan Net Product Revenues


$225


to


$250


$210


to


$235

Brineura Net Product Revenues


$145


to


$160


Unchanged

Voxzogo Net Product Revenues


$100


to


$125


$130


to


$160














Cost of Sales (% of Total Revenues)


23.0 %


to


25.0 %


22.5 %


to


24.5 %

Research and Development Expense


$665


to


$715


Unchanged

Selling, General and Administrative Expense


$790


to


$840


Unchanged














GAAP Net Income


$95


to


$135


$105


to


$145

Non-GAAP Income (1)


$350


to


$390


Unchanged

 

(1)

All Financial Guidance items are calculated based on U.S. GAAP with the exception of Non-GAAP Income. 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 corresponding GAAP reported information.

BioMarin will host a conference call and webcast to discuss second quarter and year to date 2022 financial results today, Wednesday, August 3, 2022 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: 800-231-0316

Replay Dial-in Number: 800-645-7964

International Dial-in Number: 314-696-0504

Replay International Dial-in Number: 757-849-6722

Conference ID: 8072033

Conference ID: 2361#

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of seven commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases. 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, Net Product Revenues, Research and Development Expense, Selling, General and Administrative Expense, Cost of Sales, GAAP Net Loss, Non-GAAP Income, and other specified income statement guidance for the full-year 2022; cash flows from operating activities; 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) BioMarin's plans to re-submit a BLA for Roctavian to the FDA by the end of September 2022, (ii) BioMarin's anticipated IND submission for BMN 351 in winter, (iii) BioMarin's anticipated IND submission for BMN 349 in the second half of 2023, (iv) BioMarin's collaboration with DiNAQOR to create gene therapies including BioMarin's goal to file an IND for BMN 293 (formerly DiNA-001) in 2023, and (v) BioMarin's plans to initiate discussions with regulatory health authorities to discuss next steps regarding efforts to expand access to Voxzogo for infants and young children up to five years of age with achondroplasia; the potential approval and commercialization of BioMarin's product candidates, including Roctavian for the treatment of severe hemophilia A, and the timing of such approval decisions, including (i) the anticipated start of commercial sales of Voxzogo in Japan and Australia, (ii) the expectation of a final approval decision for Roctavian from the European Commission in the third quarter of 2022, (iii) the anticipated commercial launch of Roctavian in Europe in the third quarter of 2022 if the product candidate is approved and (iv) the duration of the FDA's review procedure of our BLA resubmission for valoctocogene roxaparvovec; and the expected benefits and availability of BioMarin's product candidates; and potential growth opportunities and trends, including that BioMarin expects (i) double-digit growth in revenues and profitability in 2022, and (ii) increasing access to Voxzogo as the product launch continues in future quarters.

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, including BioMarin's projected impact of the COVID-19 pandemic on its global revenue sources, including due to demand interruptions such as missed patient infusions and delayed treatment starts for new patients; results and timing of current and planned preclinical studies and clinical trials, as well as the potential impact of the COVID-19 pandemic on (i) BioMarin's ability to continue such preclinical studies and clinical trials and (ii) the timing of such 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, including the potential impact of the COVID-19 pandemic on the regulatory authorities' abilities to issue such decisions and the timing of such decisions; the market for each of these products; actual sales of BioMarin's commercial products and the impact that the COVID-19 pandemic may have on such sales; 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 March 31, 2022 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. RoctavianTM is a trademark of BioMarin Pharmaceutical Inc. 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.

 

BIOMARIN PHARMACEUTICAL INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

June 30, 2022 and December 31, 2021

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



June 30, 2022


December 31, 2021 ?¹?

ASSETS

(unaudited)



Current assets:




Cash and cash equivalents

$                       619,802


$                       587,276

Short-term investments

489,945


426,599

Accounts receivable, net

466,507


373,399

Inventory

802,315


776,669

Other current assets

139,029


110,442

Total current assets

2,517,598


2,274,385

Noncurrent assets:




Long-term investments

412,503


507,793

Property, plant and equipment, net

1,049,464


1,035,461

Intangible assets, net

369,368


388,652

Goodwill

196,199


196,199

Deferred tax assets

1,448,912


1,449,075

Other assets

151,797


151,760

Total assets

$                    6,145,841


$                    6,003,325

LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable and accrued liabilities

$                       434,773


$                       491,590

Short-term contingent consideration

29,954


48,232

Total current liabilities

464,727


539,822

Noncurrent liabilities:




Long-term convertible debt, net

1,081,047


1,079,077

Long-term contingent consideration

?


15,167

Other long-term liabilities

95,260


98,519

Total liabilities

1,641,034


1,732,585

Stockholders' equity:




Common stock, $0.001 par value: 500,000,000 shares authorized; 185,452,454 and 183,912,514 shares issued and outstanding, respectively

186


184

Additional paid-in capital

5,272,666


5,191,502

Company common stock held by the Nonqualified Deferred Compensation Plan

(9,290)


(9,689)

Accumulated other comprehensive income

18,472


14,432

Accumulated deficit

(777,227)


(925,689)

Total stockholders' equity

4,504,807


4,270,740

Total liabilities and stockholders' equity

$                    6,145,841


$                    6,003,325





 

(1)

December 31, 2021 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, 2021, filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2022.

 

BIOMARIN PHARMACEUTICAL INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Six Months Ended June 30, 2022 and 2021

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

(unaudited)



Three Months Ended June 30,


Six Months Ended June 30,


2022


2021


2022


2021

REVENUES:








Net product revenues

$            517,660


$            486,670


$         1,023,185


$            954,439

Royalty and other revenues

16,138


15,023


29,972


33,284

Total revenues

533,798


501,693


1,053,157


987,723

OPERATING EXPENSES:








Cost of sales

123,126


127,062


240,091


247,228

Research and development

158,190


161,107


319,026


309,832

Selling, general and administrative

196,835


184,161


391,454


358,479

Intangible asset amortization and contingent consideration

16,495


17,691


34,107


35,426

Gain on sale of nonfinancial assets, net

?


?


(108,000)


?

Total operating expenses

494,646


490,021


876,678


950,965

INCOME FROM OPERATIONS

39,152


11,672


176,479


36,758









Interest income

2,505


4,471


4,325


6,910

Interest expense

(3,859)


(3,817)


(7,665)


(7,621)

Other income (expense), net

(2,947)


1,830


(4,101)


1,337

INCOME BEFORE INCOME TAXES

34,851


14,156


169,038


37,384

Provision for income taxes

7,187


1,215


20,576


7,072

NET INCOME

$              27,664


$             12,941


$            148,462


$             30,312

NET INCOME PER SHARE, BASIC

$                  0.15


$                 0.07


$                 0.80


$                 0.17

NET INCOME PER SHARE, DILUTED

$                  0.15


$                 0.07


$                 0.79


$                 0.16

Weighted average common shares outstanding, basic

185,254


182,844


184,710


182,311

Weighted average common shares outstanding, diluted

187,448


185,427


191,096


185,089

 

BIOMARIN PHARMACEUTICAL INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months Ended June 30, 2022 and 2021

(In thousands of U.S. dollars)

(unaudited)



Six Months Ended June 30,


2022


2021

CASH FLOWS FROM OPERATING ACTIVITIES:




Net income

$              148,462


$               30,312

Adjustments to reconcile net income to net cash provided by operating activities:




Depreciation and amortization

52,614


55,214

Non-cash interest expense

2,062


2,082

Amortization of premium on investments

3,070


1,878

Stock-based compensation

94,911


104,346

Gain on sale of nonfinancial assets, net

(108,000)


?

Deferred income taxes

3,455


1,204

Unrealized foreign exchange gain

(12,333)


(1,004)

Non-cash changes in the fair value of contingent consideration

1,338


4,488

Other

(18)


(376)

Changes in operating assets and liabilities:




Accounts receivable, net

(92,562)


17,420

Inventory

(1,431)


6,379

Other current assets

(12,001)


34,331

Other assets

9,149


321

Accounts payable and other short-term liabilities

(76,345)


(60,884)

Other long-term liabilities

(1,576)


585

Net cash provided by operating activities

10,795


196,296

CASH FLOWS FROM INVESTING ACTIVITIES:




Purchases of property, plant and equipment

(55,971)


(48,106)

Maturities and sales of investments

311,598


348,941

Purchases of investments

(304,805)


(484,572)

Proceeds from sale of nonfinancial assets

110,000


?

Purchase of intangible assets

(2,739)


(6,400)

Other

?


(908)

Net cash provided by (used in) investing activities

58,083


(191,045)

CASH FLOWS FROM FINANCING ACTIVITIES:




Proceeds from exercises of awards under equity incentive plans

29,493


27,640

Taxes paid related to net share settlement of equity awards

(44,377)


(38,731)

Payment of contingent consideration

(21,054)


?

Principal repayments of financing leases

(1,122)


(1,941)

Other

?


(381)

Net cash used in financing activities

(37,060)


(13,413)

Effect of exchange rate changes on cash

708


537

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

32,526


(7,625)

Cash and cash equivalents:




Beginning of period

$              587,276


$              649,158

End of period

$              619,802


$              641,533

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 Income/Loss excluding net interest expense, provision for 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 Income/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.

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 and its components 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, 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 Income to Non-GAAP Income:

Reconciliation of GAAP Net Income to Non-GAAP Income

(In millions of U.S. dollars)

(unaudited)



Three Months Ended

June 30,


Six Months Ended

June 30,


Guidance (1)

Year Ending


2022


2021


2022


2021


December 31, 2022













GAAP Net Income

$         27.7


$           12.9


$         148.5


$           30.3


$   105.0

to

$   145.0













Interest income (expense), net

1.4


(0.7)


3.3


0.7


7.0

Provision for income taxes

7.2


1.2


20.6


7.1


44.0

Depreciation expense

9.5


11.8


21.2


24.3


42.0

Amortization expense

15.6


15.5


31.2


30.9


63.0

Stock-based compensation expense

47.1


54.9


94.9


104.3


192.0

Contingent consideration expense

0.9


2.2


2.9


4.5


5.0

Gain on sale of nonfinancial assets, net

?


?


(108.0)


?


(108.0)

Non-GAAP Income

$       109.4


$           97.8


$         214.6


$         202.1


$   350.0

to

$   390.0

 

(1)

The adjustments/reconciling items included in the Guidance Year Ending December 31, 2022 column are presented to facilitate the reconciliation of Non-GAAP Income to its closest GAAP financial metric, GAAP Net Income. The Company notes that the specific amounts included in each reconciling line item above represent approximations of the underlying adjustments from GAAP Net Income to Non-GAAP Income, and that actual 2022 results for each reconciling line item may be different, in some cases materially, than the amounts listed above as a result of uncertainty regarding, and the potential variability of, those items.

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,


2022


2021




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

$        123.1


$                ?


$               (4.8)


$     118.3


$     127.1


$              ?


$                 (6.1)


$      121.0

Research and development

158.2


(5.3)


(13.6)


139.3


161.1


(7.1)


(20.8)


133.2

Selling, general and administrative

196.8


(4.2)


(28.7)


163.9


184.2


(4.7)


(28.0)


151.5

Intangible asset amortization and contingent consideration

16.5


(15.6)


(0.9)


?


17.7


(15.5)


(2.2)


?

Interest income (expense), net

(1.4)


1.4


?


?


0.7


(0.7)


?


?

Provision for income taxes

7.2


(7.2)


?


?


1.2


(1.2)


?


?

GAAP Net Income /Non-GAAP Income

$          27.7


$             33.7


$              48.0


$     109.4


$       12.9


$           27.8


$                57.1


$        97.8

 


Six Months Ended June 30,


2022


2021




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

$        240.1


$                ?


$               (9.1)


$     231.0


$     247.2


$              ?


$               (12.6)


$      234.6

Research and development

319.0


(12.7)


(30.8)


275.5


309.8


(14.6)


(38.3)


256.9

Selling, general and administrative

391.5


(8.5)


(55.0)


328.0


358.5


(9.7)


(53.4)


295.4

Intangible asset amortization and contingent consideration

34.1


(31.2)


(2.9)


?


35.4


(30.9)


(4.5)


?

Gain on sale of nonfinancial assets, net

(108.0)


?


108.0


?


?


?


?


?

Interest expense, net

(3.3)


3.3


?


?


(0.7)


0.7


?


?

Provision for income taxes

20.6


(20.6)


?


?


7.1


(7.1)


?


?

GAAP Net Income / Non-GAAP Income

$        148.5


$             76.3


$             (10.2)


$     214.6


$       30.3


$           63.0


$              108.8


$      202.1

 

Contact:



Investors:


Media:

Traci McCarty


Debra Charlesworth

BioMarin Pharmaceutical Inc.


BioMarin Pharmaceutical Inc.

(415) 455-7558


(415) 455-7451

 

SOURCE BioMarin Pharmaceutical Inc.


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