First Quarter 2021 Results

May 13th, 2021

Laboratorios Farmacéuticos Rovi, S.A. and Subsidiaries

Investor Relations

Laboratorios Farmacéuticos Rovi, S.A. and Subsidiaries

ROVI - First Quarter 2021 Financial Results

ROVI reports operating revenue growth of 29% and EBITDA growth of 74%

  • Operating revenue increased by 29% to 130.5 million euros in the first quarter of 2021, driven by (i) the strength of the toll manufacturing business, which grew by 179%, and (ii) the specialty pharmaceutical business, where sales rose 8%. Total revenue increased by 29% to 130.9 million euros in the first quarter of 2021.
  • In February 2021, ROVI announced it expected the operating revenue for the full year 2021 to increase between 20% and 30%, including the production of the Moderna's COVID-19 vaccine. As a result of the expansion of the collaboration between ROVI and Moderna, for 2021 ROVI expects to achieve the higher end of this range. Notwithstanding, given the uncertainties associated to the development of the COVID-19 pandemic (which ROVI will continue to monitor closely), it is not yet possible to make a precise assessment of the impact that the pandemic will have on this year.
  • Sales of the heparin franchise (Low Molecular Weight Heparins (LMWH) and other heparins) increased by 15% to 63.9 million euros in the first quarter of 2021. Heparin sales represented 49% of operating revenue in the first quarter of 2021 compared to 55% in the first quarter of 2020. Sales of LMWH (Enoxaparin biosimilar and Bemiparin) increased by 15% to 62.2 million euros in the first quarter of 2021. Sales of the enoxaparin biosimilar decreased 1% to 29.4 million euros in the first quarter of 2021 and sales of Bemiparin increased 35% to 32.8 million euros.
  • Sales of Neparvis®, launched in December 2016, increased by 10% to 8.7 million euros in the first quarter of 2021.
  • EBITDA increased by 74%, from 20.0 million euros in the first quarter of 2020 to 34.8 million euros in the first quarter of 2021, reflecting a 6.9 percentage point rise in the EBITDA margin to 26.7% in the first quarter of 2021.
  • Net profit increased by 71%, from 13.9 million euros in the first quarter of 2020 to 23.8 million euros in the first quarter of 2021.

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ROVI - First Quarter 2021 Financial Results

Laboratorios Farmacéuticos Rovi, S.A. and Subsidiaries

  • ROVI strengthens its collaboration with Moderna (i) in the fill-finish of the COVID-19 Vaccine Moderna by increasing its fill-finish capacity (see section 7.1), and (ii) for the manufacture of the active substance of this vaccine (see section 7.2). To this end, further industrial investments will be made in the ROVI Group's facilities in Madrid and Granada.

Madrid (Spain), 13th May 2021, 8:00 AM CET - ROVI released today its financial results for the first quarter of 2021.

Juan López-Belmonte Encina, Chief Executive Officer of ROVI, said "At the time of presenting these results, it has been a little over a year since the WHO declared the COVID-19pandemic in March 2020. Since then, all our efforts have been directed towards protecting our employees and ensuring that patients who needed our medicines had them and were not affected by global lockdowns. Fortunately, it seems that in 2021 we are starting to see the light at the end of the tunnel thanks to the development of COVID-19vaccines. One of those vaccines is the Moderna vaccine, in which ROVI is currently involved regarding its fill and finish and, with the expansion of the agreement with Moderna, we will be also involved in the manufacture of the active substance. Mass vaccination programmes are already in progress all around the globe and we are very proud for our work to contribute to this historic moment. Regarding ROVI's 2021 first quarter results, we achieved 29% operating revenue growth, mainly driven by the strength of the toll manufacturing business, which grew by 179% and by the specialty pharmaceutical business, where sales rose 8%. We forecast continued growth thanks to, among other factors, our flagship product, Bemiparin, which grew by 35%. Likewise, we are already marketing our enoxaparin biosimilar in 19 countries in the first quarter of 2021. We are in a phase of international expansion and hope that our enoxaparin biosimilar will enable us to be present in more than 120 countries in the long term. We are very excited about the potential of our LMHW franchise and aspire to become a benchmark player in this field worldwide. Furthermore, we expect our specialty business in Spain, supported by the good performance of products such as Neparvis®, from Novartis, and Volutsa®, from Astellas, to provide us with a sustainable and profitable growth opportunity in the future. Furthermore, (i) the agreement signed with Moderna and (ii) the redirection of the toll manufacturing activities strategy towards high value- added products, backed by the high degree of technological specialisation of our plants in differentiated niches, enabled our toll manufacturing business to increase 179% in the first quarter of 2021.

At the same time, we are confident of the potential of our current pipeline of R&D projects, making important investment efforts, since we trust they will be the company's growth engine in the future. We have high hopes of the potential of our long-acting injectable technology (ISM®). We are currently undergoing a regulatory process with our first candidate, Risperidone ISM®, based on our ISM® technology, in Europe and the United States in order to obtain the

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ROVI - First Quarter 2021 Financial Results

Laboratorios Farmacéuticos Rovi, S.A. and Subsidiaries

marketing authorisation for Risperidone ISM® in both territories. We expect to launch this product on the market in 2022. We are also conducting a Phase I study for another candidate, Letrozole, for which preliminary data likewise show positive results, reflecting our clear commitment to our ISM® technology".

1. Financial highlights

€ million

Q1 2021

Q1 2020

Growth

% Growth

Operating revenue

130.5

101.0

29.6

29%

Other income

0.3

0.3

0.1

23%

Total revenue

130.9

101.2

29.6

29%

Cost of goods sold

-60.8

-46.0

-14.7

32%

Gross profit

70.1

55.2

14.9

27%

% margin

53.7%

54.7%

-0.9pp

R&D expenses

-5.8

-4.5

-1.4

30%

SG&A

-29.5

-30.8

1.2

-4%

Share of profit of a joint venture

0.0

0.0

0.0

41%

EBITDA

34.8

20.0

14.8

74%

% margin

26.7%

19.8%

6.9pp

EBIT

29.6

15.1

14.5

96%

% margin

22.7%

15.0%

7.7pp

Net profit

23.8

13.9

9.9

71%

Non-audited figures

Note: certain numerical figures included in this document have been rounded. Therefore, discrepancies in tables between totals and the sums of the amounts listed may occur due to such rounding.

The consolidated financial statements of Grupo ROVI for the first quarter of 2021 and the comparative information for 2020 (balance sheet) and for the first quarter of 2020 (consolidated income statement and cash flow statement) are attached to this report (see Appendix 1).

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ROVI - First Quarter 2021 Financial Results

Laboratorios Farmacéuticos Rovi, S.A. and Subsidiaries

2. Performance of the Group

Operating revenue increased by 29% to 130.5 million euros in the first quarter of 2021, driven by the strength of the toll manufacturing business, which grew by 179%, and by the specialty pharmaceutical business, where sales rose 8%. Total revenue increased by 29% to 130.9 million euros in the first quarter of 2021.

€ million

Q1 2021

Q1 2020

% Growth

Specialty pharmaceutical business

95.0

88.2

8%

Toll manufacturing business

35.6

12.7

179%

Operating revenue

130.5

101.0

29%

Sales of prescription-basedpharmaceutical products rose 8% to 86.2 million euros in the first quarter of 2021.

€ million

Q1 2021

Q1 2020

% Growth

Prescription-based pharmaceutical products

86.2

79.7

8%

LMWH franchise

62.2

53.9

15%

Biosimilar of enoxaparin

29.4

29.6

-1%

Bemiparin (Hibor)

32.8

24.3

35%

Sales in Spain

18.9

18.3

3%

International sales

13.9

6.0

132%

Neparvis

8.7

7.9

10%

Ulunar & Hirobriz

2.5

3.8

-35%

Volutsa

3.9

3.8

2%

Vytorin & Absorcol & Orvatez

6.8

9.5

-29%

Medikinet & Medicebran

0.9

1.1

-13%

Other products

6.5

7.5

-13%

Discounts to the National Health System

-5.3

-7.9

-32%

Contrast agents and other hospital products

8.5

8.3

2%

OTC and Other

0.3

0.2

34%

Total specialty pharmaceutical business

95.0

88.2

8%

Sales of the heparin franchise (Low Molecular Weight Heparins and other heparins) increased by 15% to 63.9 million euros in the first quarter of 2021. Heparin sales represented 49% of operating revenue in the first quarter of 2021 compared to 55% in in the first quarter of 2020.

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ROVI - First Quarter 2021 Financial Results

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Laboratorios Farmacéuticos ROVI SA published this content on 13 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 May 2021 05:53:09 UTC.