BioMarin Announces First Quarter 2021 Financial Results and Corporate Updates


SAN RAFAEL, Calif., April 29, 2021 /PRNewswire/ —

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



Three Months Ended March 31,



2021


2020


% Change








Total Revenues


$

486.0



$

502.1



(3)

%








Net Product Revenues Marketed by BioMarin (1)


$

417.8



$

433.3



(4)

%








Vimizim Net Product Revenues


$

158.4



$

137.2



15

%

Naglazyme Net Product Revenues


$

107.3



$

114.3



(6)

%

Kuvan Net Product Revenues


$

70.8



$

122.0



(42)

%

Palynziq Net Product Revenues


$

54.0



$

34.6



56

%

Brineura Net Product Revenues


$

27.3



$

24.0



14

%








Aldurazyme Net Product Revenues


$

50.0



$

55.7



(10)

%








GAAP Net Income


$

17.4



$

81.4




GAAP Net Income per Share – Basic


$

0.10



$

0.45




GAAP Net Income per Share – Diluted


$

0.09



$

0.44




Non-GAAP Income (2)


$

104.4



$

116.5





March 31,
2021


December 31,
2020


Cash, cash equivalents and investments

$

1,408.6



$

1,350.9





(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). Sanofi Genzyme (Genzyme) is BioMarin’s sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. Refer to page 9 for a table showing Net Product Revenues by product. In January 2020, BioMarin divested the Firdapse assets to a third party in a sale transaction. The sale is reflected in the Company’s consolidated financial statements for the first quarter ended March 31, 2020; as a result of the transaction BioMarin will not recognize Net Product Revenues from Firdapse in the future.

(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 11 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, 2021.

“We mark the start of 2021 with strong financial results, and a number of exciting regulatory decisions ahead this year,” said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. “The potential approval in Europe this summer of vosoritide, the first potential therapeutic option for children with achondroplasia, will set the stage for our next significant phase of growth, especially considering the EMEA region is 3 times larger than the U.S. market. To date, the interactions with the review team at the European Medicines Agency have been very positive. Next, we plan to re-submit the application for valoctocogene roxaparvovec gene therapy, to treat hemophilia A, to the EMA in the second quarter, to be followed by potential approval of vosoritide in the United States later this year.”

Mr. Bienaimé continued, “We are well positioned to deliver strong results for the full-year 2021, and reaffirm our financial guidance provided early this year. This takes into consideration the uneven ordering patterns in our dynamic and global commercial business, as well as continued uncertainty outside of the United States from COVID-19, and further underscores the essential nature of our products to the people who rely on them. Taken together, our financial strength, including positive cash flows from operations of $113.5 million in the first quarter, combined with near-term opportunities from potential new products and a robust early-stage pipeline, we believe that 2021 will be pivotal to BioMarin’s evolution.” 

Financial Highlights:

  • Net Product Revenues for the first quarter of 2021 decreased to $467.8 million, compared to $489.0 million for the same period in 2020. The decrease in Net Product Revenues was primarily attributed to the following:
    • Lower Kuvan product revenues primarily due to known generic competition in the U.S.; partially offset by
    • Higher Vimizim product revenues primarily due to timing of orders from Europe, Middle East and North Africa; and
    • Higher Palynziq product revenues primarily driven by a combination of revenue from more U.S. patients achieving maintenance dosing and new patients initiating therapy.
  • GAAP Net Income decreased $64.0 million to $17.4 million for the first quarter of 2021 compared to $81.4 million for the same period in 2020. The decrease was primarily due to the absence of the gain on sale the Firdapse commercial assets totaling $59.5 million in the first quarter of 2020 and a decrease in gross profits due to the lower Kuvan product revenues due to generic competition in the U.S. This decrease was partially offset by lower selling, general and administrative (SG&A) expenses primarily due to a decrease in foreign currency exchange losses in the first quarter of 2021.
  • Non-GAAP Net Income for the first quarter of 2021 decreased to $104.4 million compared to Non-GAAP Income of $116.5 million for the same period in 2020. The decline in Non-GAAP Income for the quarter, compared to the same period in 2020, was primarily attributed to lower gross profits, partially offset by lower SG&A expenses primarily due to a decrease in foreign currency exchange losses in the first quarter of 2021.

Commercial Portfolio (Naglazyme, VIMIZIM, Brineura, Palynziq, Kuvan and Aldurazyme) 

  • Naglazyme, VIMIZIM and Brineura maintained robust patient compliance in the quarter and continue to grow based on strong underlying demand.
    • Patients on commercial Naglazyme and Vimizim therapy both increased approximately 10% year-over-year.
    • Patients on commercial Brineura therapy increased by more than 30% year-over-year.
  • Order timing for both Naglazyme and VIMIZIM are expected to be more concentrated in the first half of 2021 as compared to the second half of 2021.
  • Palynziq top-line results in 2021 are expected to increase approximately 35% based on the mid-point of full-year 2021 guidance as compared to full-year 2020 results.
  • Palynziq growth in European, Middle East and African regions (EMEA) has been impacted by ongoing challenges due to COVID-19 with Palynziq revenue from EMEA expected to increase when PKU clinics have more freedom to operate and start additional patients.
    • The number of U.S. Patients on commercial Palynziq therapy increased more than 20% year-over-year and is expected to continue to grow as U.S. PKU clinics re-open over the coming quarters.
  • Loss of Kuvan U.S. market share, due to the introduction of generics following BioMarin’s loss of U.S. market exclusivity, is consistent with expectations.
  • Aldurazyme contributions were driven by the timing of product released and transfer of control to Genzyme, who is responsible for marketing Aldurazyme worldwide.

Late-stage Regulatory Portfolio (Vosoritide and valoctocogene roxaparvovec)

  • In Europe, with respect to vosoritide for the treatment of achondroplasia, BioMarin is in the final stages of the review procedure ahead of the anticipated June 2021 Committee for Medicinal Products for Human Use (CHMP) opinion. Assuming a positive CHMP opinion, the European Commission could potentially grant marketing authorization for vosoritide in the third quarter of 2021.
  • In Europe, with respect to valoctocogene roxaparvovec for the treatment of severe hemophilia A, based on positive pre-submission feedback in the current quarter, BioMarin reaffirms its plan to submit the Marketing Authorization Application…



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