Laboratorios Farmaceuticos Rovi S A : ROVI releases the presentation related to the first quarter 2020 financial results

F I R S T Q U A R T E R 2 0 2 0 F I N A N C I A L R E S U L T S

M A Y 2 0 2 0

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Operating results

Q1 2020 financial results - Highlights

• Operating revenue increased by 23% to €101.0Mn in Q1 2020, driven by the strength of the specialty pharmaceutical business, where sales rose 24%, strongly outperforming the market, and by the toll manufacturing business, which grew by 19%. Total revenue increased by 23% to €101.2Mn in Q1 2020. This significant increase is partially due to the extraordinary sales in March as a result of the medicine stockpiling by the entire distribution chain due to the Covid-19 crisis.
• For 2020, ROVI expects a mid-single-digit growth rate for the operating revenue. Notwithstanding, given the uncertainties associated to the development of the Covid-19pandemic and the duration of the State of Alarm, it is not yet possible to make a precise assessment of the impact that the pandemic will have on the current year. ROVI expects the main negative impact on group sales to take place in the second quarter of 2020.
• Sales of the heparin franchise (Low Molecular Weight Heparins (LMWH) and other heparins) increased by 42% to €55.6Mn in Q1 2020. Heparin sales represented 55% of operating revenue in Q1 2020 compared to 48% in Q1 2019. Sales of LMWH (Enoxaparin biosimilar and Bemiparin) increased by 43% to €53.9Mn in Q1 2020. Sales of the Enoxaparin biosimilar amounted to €29.6Mn (+79%) in Q1 2020 and positive performance of Bemiparin (+15% to €24.3Mn).
• Sales of Neparvis, launched in December 2016, increased 85% to €7.9Mn in Q1 2020.
• EBITDA increased by 68%, from €11.9Mn in Q1 2019 to €20.0Mn in Q1 2020, reflecting a 5.3 pp rise in the EBITDA margin to 19.8% in Q1 2020.
• Net profit increased by 102%, from €6.9Mn in Q1 2019 to €13.9Mn in Q1 2020.
• ROVI filed its application for marketing authorisation for Doria® with the European health authorities, the European Medicines Agency (EMA), through the Centralised Procedure on 27 December, 2019. After passing the validation phase satisfactorily, the dossier was admitted for evaluation on 30 January, 2020.

1

Growth driven by specialty pharma and toll manufacturing businesses…

Total operating revenue (€Mn)					Operating revenue growth by category (€Mn)
120		+23%			120						101,0
							100						12,7
											82,2	+19%
80							80		10,7
							60
					101,0									+24%	88,2
40		82,2					40
						71,4
							20
0							0
	Q1 2019	Q1 2020				Q1 2019			Q1 2020
													Specialty pharma			Toll manufacturing

• Operating revenue increased by 23% to €101.0Mn in Q1 2020 driven by the strength of:
• • the specialty pharmaceutical business, where sales rose 24%; and
  • the toll manufacturing business, which grew by 19%.

2

…with high profitability

EBITDA (€Mn) and EBITDA margin (%)

					19,8%
20%					+68%		20
	14,4%
15%					20,0		15
10%		11,9		10
5%									5
0%									0
	Q1 2019			Q1 2020
				EBITDA			EBITDA margin

Net profit (€Mn)

15

+102%

10

13,9

5

6,9

0

Q1 2019

Q1 2020

• EBITDA increased by 68%, from €11.9Mn in Q1 2019 to €20.0Mn in Q1 2020, reflecting a 5.3 percentage point rise in the EBITDA margin to 19.8% in Q1 2020.
• Net profit increased by 102%, from €6.9Mn in Q1 2019 to €13.9Mn in Q1 2020.

3

Heparins, leading the specialty pharmaceutical business

Prescription-based pharma products sales (€Mn)

80

+27%

60

40

79,7

62,7

20

0

Q1 2019

Q1 2020

Heparin franchise sales (€Mn)

60%			55,1%		60
47,6%
40%			55,6		40
20%		39,1			20

0%						0
		Q1 2019		Q1 2020
			Heparins		Heparins/operating revenue

• Sales of prescription-based pharmaceutical products increased by 27% to €79.7Mn in Q1 2020.
• Sales of the heparin franchise (Low Molecular Weight Heparins (LMWH) and other heparins) increased by 42% to 55.6 million euros in Q1 2020.
• Heparin sales represented 55% of operating revenue in Q1 2020 compared to 48% in Q1 2019.

4

Well Positioned to Drive Long-Term Leadership in Low Molecular Weight Heparins (LMWH)

LMWH sales (€Mn)		Bemiparin sales (€Mn)

60

40

20

0

•

24,3

				+43%	53,9		25		21,1	+15%
															6,0
										20		3,5	+69%
	37,6
	+79%	29,6
										15
	16,5
				+15%				10					+4%
									17,6	18,3
	21,1				24,3		5
										0
	Q1 2019					Q1 2020
						Q1 2019			Q1 2020
			Bemiparin					Enoxaparin biosimilar					Spain			International sales

Sales of LMWH (Enoxaparin biosimilar and Bemiparin) increased by 43% to €53.9Mn in Q1 2020.

• Sales of the Enoxaparin biosimilar amounted to €29.6Mn (+79%) in Q1 2020.
• Bemiparin total sales increased by 15% to €24.3Mn in Q1 2020:
• • Sales in Spain increased 4% to €18.3Mn.
  • International sales increased by 69% to €6.0Mn. This significant increase was specifically linked to Q1 2020 and ROVI expects international Bemiparin sales to decrease by a mid-single-digit percentage in 2020.

5

Strong growth potential of Enoxaparin Biosimilar Becat®

Strong Commercial Launch with a Clear Strategy		Well-Established Network to Minimize Time-to-Market

• ROVI launched enoxaparin biosimilar Becat® in Germany (first EU market) in September 2017; in UK, Italy, Spain, France1, Austria, Latvia and Estonia in 2018; and in Portugal, Poland, Costa Rica, Finland and Sweden in 2019.
• Newly-establishedEuropean sales offices provide pan-Europeaninfrastructure that is highly leverageable for further growth of ROVI's heparin franchise and broader portfolio.

Enoxaparin Biosimilar Becat® Sales Ramp-up

VERY POSITIVE EVOLUTION OF ENOXAPARIN BIOSIMILAR
BECAT® SALES SINCE LAUNCH IN 4Q17	+79%

Direct
Marketed in	Approved in
		Pending
Germany, UK,	26 countries in	Launched in 13
Europe and 6	approval in	70
Italy, Spain,	countries
in the Rest of	countries
Portugal and
the World
Poland
	Stage I of Commercial Strategy
Focus on Europe…	ROVI will directly market

enoxaparin biosimilar	In the long-term,
Becat® in 7 European	biosimilars tend to
countries…	reach a…

30

25

€m

+2.7x

€80.9Mn

50-70%

Market Share5

20

…the largest enoxaparin	…which account for
market with €0.9bn
c.75% of the European
sales3	market4

…of the reference

product market

15

10

5

		€30.2Mn					29,6
						20,0	28,0
1,5	4,1	4,8	7,8	13,5	16,5	16,3

Stage II of Commercial Strategy

Continue international expansion in other markets with strong growth potential through out-licensing agreements

Already Signed Out-Licensed Agreements: 87 Countries

€0.5bn 13.9%

20192019 Market Sales3 Market Growth3

0

Q4 2017	2	Q2 2018	Q3 2018	Q4 2018	Q1 2019	Q2 2019	Q3 2019	Q4 2019	Q1 2020
Q12018

ROVI signed a licensing agreement with Sandoz to distribute enoxaparin biosimilar Becat® in 14 countries/regions and with Hikma in 17 Middle East and North African countries.

1.	ROVI has started to sell Becat® in France though Biogaran	4.	QuintilesIMS, 2015.
2.	Becat® 4Q 2017 sales include sales throughout September. As the product was launched that month, sales were negligible.	5.	Technavio 2016 biosimilars report.
3.	Estimates based on Sanofi-Aventis reported 2019 sales.

6

Strong performance of the product portfolio (1/2)

Neparvis sales (€Mn)

8

6+85%

4

7,9

24,3

0

Q1 2019

Q1 2020

Medicebran and Medikinet sales (€Mn)

3

-49%

2

1	2,1
		1,1
0
Q1 2019	Q1 2020

Volutsa sales (€Mn)

4			+23%
3
2		3,1	3,8
1
0
	Q1 2019			Q1 2020

• Sales of Neparvis, a specialty product from Novartis launched in December 2016, increased by 85% to €7.9Mn in Q1 2020, from €4.3Mn in Q1 2019.
• Sales of Volutsa, launched in Spain in February 2015, increased by 23% to €3.8Mn in Q1 2020.
• Sales of Medicebran and Medikinet, products launched in December 2013 and marketed on exclusivity basis by ROVI in Spain, decreased 49% to €1.1Mn in Q1 2020. In July 2019, Medikinet® (methylphenidate hydrochloride with a modified release) went out of protection for galenic innovation and its price was reduced by 50.3% on average.

Neparvis is a specialty product from Novartis indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction.

Volutsa is a specialty product from Astellas Pharma indicated for the treatment of moderate to severe storage symptoms and voiding symptoms associated with benign prostatic hyperplasia. Medicebran and Medikinet are specialty products from Medice indicated for the treatment of ADHD in children and teenagers.

7

Strong performance of the product portfolio (2/2)

Absorcol, Vytorin and Orvatez sales (€Mn)			Hirobriz and Ulunar sales (€Mn)
10			+31%	4
8
				3
6
			9,5	2		3,8	3,8
4		7,3
				1
2
0				0
				Q1 2019	Q1 2020
	Q1 2019	Q1 2020

Contrast imaging agents sales (€Mn)

10

+1%

8

6

4

8,2

8,3

2

0

Q1 2019

Q1 2020

• Sales of Vytorin®, Orvatez® and Absorcol® increased by 31% to €9.5Mn in Q1 2020. In Q2 2018, the active principle ezetimibe went out of patent and the price of Absorcol® was reduced. Likewise, generics formulated with ezetimibe and simvastatin were marketed in the same period, so the price of Vytorin® was reduced to be competitive. In addition, Orvatez® price is expected to be reduced by 30% throughout the first half of 2020 due to the entrance of hybrid products formulated with ezetimibe and atorvastatine.
• Sales of Hirobriz and Ulunar, both products for patients with COPD, launched in Spain in Q4 2014 remained stable at €3.8Mn in Q1 2020.
• Contrast imaging agents and other hospital products increased by 1% to €8.3Mn in Q1 2020. This slight increase is mainly due to the significant reduction in the number of diagnostic tests performed during the period of confinement.

Vytorin, Orvatez and Absorcol, the first of the five licenses of MSD, are indicated for the treatment of hypercholesterolemia.

Hirobriz Breezhaler and Ulunar Breezhaler are both products from Novartis indicated for the treatment of COPD (Chronic Obstructive Pulmonary Disease).

8

Value added toll manufacturing services

Toll manufacturing sales (€Mn)

			• Toll manufacturing sales increased by 19% to 12.7 million euros in Q1 2020 as
15			a result of the redirection of our toll manufacturing activities strategy towards
		high-value-added products.
+19%

• In November 2019, the toll manufacturing management units, ROVI Contract Manufacturing and Frosst Ibérica, merged into a single entity, ROVI Pharma Industrial Services, which furnishes manufacturing services with the highest degree of quality and competitiveness. The total integration of the production

10processes is expected to allow the company to attain greater synergies and levels of efficiency in its industrial operations.

12,7

510,7

0

• Likewise, by the end of 2020, ROVI expects the toll manufacturing business to have increased by a low-double-digit percentage.

Q1 2019

Q1 2020

9

• ISM® Platform Opens Up New Avenues of Growth for ROVI

Overview

Key Company Highlights of ISM® Platform

• Internally-developedand patented innovative drug-release technology, ISM®1, which allows for the sustained release of compounds administered by injection
• • Based on two separate syringes respectively containing (a) the drug and polymer (solid state) and (b) the solvent (liquid state)
• Potential wide applicability of ISM® technology to new chronic therapeutic areas, including psychiatry and oncology
• • 505(b)(2) path of approval for candidates leveraging ISM® technology

2 Candidates Currently in Clinical Trials

Product	Potential Indication		Current Situation		Key Milestones
		Non-	I	II	III
		Clinical
DORIA®						Positive results from Phase
Risperidone,	Schizophrenia
				III. Filed in Europe.
monthly
Letrozole						Phase I started in
ISM®
Breast Cancer					November 2017
Long acting
Letrozole
Risperidone,	Schizophrenia
quarterly

Concentrated on improving posology for already approved compounds, which benefits risk / reward profile

Pop PK 2 model & simulations

1 Predictability already validated for DORIA® in Phase I & II Clinical Program

2

Usability

Improved stability

Selecting the most convenient

3 Flexibility posology depending on clinical needs

	Improved	Long acting injection (LAI)
4	Clinical	(1-6 months) plasma therapeutic
	Management	levels from day 1

			Technological barriers (e.g.
5	Vertical		power filling)
Integration		Strong IP
			Manufacturing capabilities

Expected high

success rate in 

Phase III

No cold chain	
needed

From 1 to 6-month	
administration

Rapid onset & sustained clinical 

effect

• Protected

technology

• Fully integrated  manufacturing

plants

Multiple FDA / GMP approved facilities to support the platform

1. ISM® stands for In Situ Microparticles®.
2. PK stands for pharmacokinetic.

10

Guidance 2020

2020 operating revenue growth rate

Mid-single-digit

T H E K E Y G R O W T H L E V E R S I N 2 0 2 0

Specialty Pharma Business

• Bemiparin
• Biosimilar of Enoxaparin
• Launches such as Neparvis and Volutsa
• Existing portfolio of specialty pharmaceuticals
• New acquisitions (Falithrom, Polaramine and sodium heparin)

Toll Manufacturing Services

• Spare capacity in the manufacturing plants
• New customers to be acquired

• Given the uncertainties associated to the development of the Covid-19 pandemic, it is not yet possible to make a precise assessment of the impact that the pandemic will have on 2020. ROVI expects the main negative impact on group sales to take place in Q2 2020.
• The potential increase in the discounts to the National Health System as a result of the Covid-19 impact may affect attainment of these growth forecasts.

11

Financial results

Good revenue level with outstanding LMWH sales growth

Total operating revenue (€Mn)		LMWH sales (€Mn)

120

80

40

0

	+23%	101,0
82,2		0,2
+19%	12,7

0,6	8,3
+1%
10,7
8,2

+27%

79,7

62,7

60

+43% 53,9

40	37,6	29,6
+79%

16,5

20

21,1	+15%	24,3

0

Q1 2019		Q1 2020	Q1 2019		Q1 2020
Prescription products		Contrast agents & other hospital products		Toll manufacturing		Other			Bemiparin		Enoxaparin biosimilar

• Operating revenue increased by 23% to €101.0Mn, achieved on:
• • 27% growth in prescription-based products;
  • 1% growth in contrast agents and other hospital products;
  • 19% increase in toll manufacturing; and
  • OTC and other revenues decreased by 58%.
• Sales of LMWH increased by 43% to €53.9Mn in Q1 2020.
• • Enoxaparin biosimilar sales increased by 79% to €29.6Mn and Bemiparin sales increased by 15%.

13

Gross margin impacted by the increase of enoxaparin biosimilar sales and the increase of LMWH raw material prices

Gross profit (€Mn) and Gross margin (%)

60%	57,0%	54,7%
50%			+18%
40%
30%			55,2
46,8
20%

10%

0%

Q1 2019

Q1 2020

•

60

40

20 •

0

Gross profit increased by 18% to €55.2Mn in Q1 2020, the gross margin showing a decrease of 2.3 pp from 57.0% in Q1 2019 to 54.7%, mainly due to:

• the €4.6Mn increase in potential discounts to the National Health System as a result of the health crisis related to the Covid-19;
• the increase of Enoxaparin biosimilar sales, which added lower margins in Q1 2020 after the launch of the product in three new markets; and
• the increase in the LMWH raw material prices (due to the African swine fever), which, in Q1 2020, were running around 40% over Q1 2019 prices.

ROVI expects this upward trend in low-molecular-weight heparin raw material prices to increase during the first part of 2020. This, together with the uncertainty about the potential impact of the Covid-19, makes the impact of these issues on the 2020 gross margin unpredictable at the present date.

Gross profit

Gross margin

14

Cost control along with commitment to R&D

SG&A expenses (€Mn)								R&D expenses (€Mn)
40%		34,1%	+10%	30,5%		30		8			-35%
				6
30%										20
							30,8			4
20%		28,0							6,9
10%										10		2			4,5
											0
0%										0
											Q1 2019			Q1 2020
			Q1 2019				Q1 2020
				SG&A				SG&A/operating revenue

• SG&A expenses rose 10% to €30.8Mn in Q1 2020 mainly due to:
• • a larger volume of enoxaparin biosimilar production;
  • the increase of €1.0Mn in personnel and other expenses related to the Covid-19 measures implemented; and
  • international subsidiaries expenses (including Portugal) which amounted to €2.4Mn compared to €2.2Mn in Q1 2019.
  • Excluding expenses related to Covid-19, SG&A would have increased by 6% to €29.7Mn in Q1 2020.
  • In 2020, expenses related to international subsidiaries are expected to be around €10Mn.
• R&D expenses decreased 35% to €4.5Mn in Q1 2020. These expenses are related to:
• • the preparation of the Doria® registration dossier to be submitted to the U.S. Food and Drug Administration (FDA);
  • the development of the Letrozole-ISM® Phase I trial; and
  • the development of a new formulation of Risperidone-ISM® for a 3-monthly injection.

15

EBITDA

EBITDA (€Mn) and EBITDA margin (%)

					19,8%
20%					+68%		20
	14,4%
15%							15
10%					20,0		10
	11,9			5
5%
0%							0
	Q1 2019	Q1 2020
				EBITDA	EBITDA margin

2019 EBITDA impacts (€Mn)

Note: EBITDA "pre-R&D" calculated excluding R&D expenses in Q1 2020 and Q1 2019

EBITDA (€Mn) and EBITDA "pre-R&D" margin (%)

30%					+30%	24,2%		30
		22,9%
25%					25
20%								20
15%						24,5		15
10%		18,8				10
5%								5
0%								0
				Q1 2019		Q1 2020
				EBITDA "pre R&D"		EBITDA margin "pre R&D"

• EBITDA increased by 68% to €20.0Mn in Q1 2020, reflecting a 5.3 pp rise in the EBITDA margin, which was up to 19.8% in Q1 2020 from 14.4% in Q1 2019.
• EBITDA "pre-R&D" increased by 30% to €24.5Mn in Q1 2020, reflecting a 1.4 pp rise in the EBITDA margin to 24.2% in Q1 2020. Likewise,
• • recognising the same amount of R&D expenses in Q1 2020 as in Q1 2019, EBITDA would have increased by 48% to €17.5Mn, reflecting a 2.9 pp rise in the EBITDA margin to 17.4% in Q1 2020.
• EBITDAC (Earnings Before Interest, Taxes, Depreciation, Amortization and Coronavirus) increased to €21.0Mn in Q1 2020, a rise of 77% compared to the same period of the previous year, reflecting a 6.3 pp increase in the EBITDAC margin, which was up to 20.8% in Q1 2020 from 14.4% in Q1 2019.

16

EBIT

EBIT (€Mn) and EBIT margin (%)

15%					15,0%		16
13%
	9,2%			12
10%
					+101%
8%					15,1		8
5%
	7,5				4
3%
0%							0
	Q1 2019	Q1 2020
				EBIT	EBIT margin

2019 EBIT impacts (€Mn)

Note: EBIT "pre-R&D" calculated excluding R&D expenses in Q1 2020 and Q1 2019.

EBIT (€Mn) and EBIT "pre-R&D" margin (%)

25%				25

					19,4%
20%									20
17,6%
15%					+36%		15
10%					19,6		10
14,4
5%									5
0%									0
		Q1 2019			Q1 2020
				EBIT "pre R&D"			EBIT margin "pre R&D"

• Depreciation and amortisation expenses increased by 12% to €4.8Mn in Q1 2020.
• EBIT increased to €15.1Mn in Q1 2020, reflecting a 5.8 pp rise in the EBIT margin, which was up to 15.0% in Q1 2020.
• EBIT "pre-R&D" increased by 36%, from €14.4Mn in Q1 2019 to €19.6Mn in Q1 2020, reflecting a 1.9 pp rise in the EBIT margin to 19.4% in Q1 2020. Likewise,
• • recognising the same amount of R&D expenses in Q1 2020 as in Q1 2019, EBIT would have increased by 69% to €12.7Mn, reflecting a 3.4 pp rise in the EBIT margin.

17

Net profit

Net profit (€Mn)

15

+102%

10

13,9

5

6,9

0

Q1 2019

Q1 2020

Net profit "pre-R&D" (€Mn)

20

+35%

15

10

18,0

13,3

5

0

Q1 2019

Q1 2020

• Net profit increased to €13.9Mn in Q1 2020, a 102% rise compared to Q1 2019.
• Net profit "pre R&D" increased by 35%, from €13.3Mn in Q1 2019 to €18.0Mn in Q1 2020. Likewise,
• • recognising the same amount of R&D expenses in Q1 2020 as in Q1 2019, net profit would have increased by 70% to €11.7Mn.
• The effective tax rate was 9.6% in Q1 2020, compared to 6.9% in Q1 2019, mainly due to the recognition in 2019 of negative tax bases ROVI had the right to use. R&D tax credits decreased in Q1 2020 as a result of the decrease in R&D expenses in Q1 2020 compared to the same period of the previous year.
• As of 31 March 2020, negative tax bases of the Group amounted to €34.9Mn, of which €8.3Mn will be used in the 2019 income tax and €0.8Mn in Q1 2020.

Note: Net profit "pre-R&D" calculated excluding R&D expenses in Q1 2020 and Q1 2019. Same effective tax rate as the reported net profit.

18

Capital expenditure and Free Cash Flow

Capex evolution (€Mn)

Capex breakdown (%)

Escuzar

4

facility; 6%

Injectables;

21%

-10%

3

ISM

industrialization;

Granada

35%

facility; 6%

2

3,3

3,0

Maintenance

1

capex and

Alcalá facility;

other; 16%

San Sebastián

8%

0

de los Reyes

•

€3.0Mn of capex invested in Q1 2020.

facility; 9%

Q1 2019

Q1 2020

• €0.6Mn of investment capex related to the injectable plant (Madrid);

Free Cash Flow (€Mn)

• €0.2Mn of investment capex related to the Granada facility;

• €0.2Mn of investment capex related to the Alcalá de Henares facility;

0

-3,1

• €0.3Mn of investment capex related to the San Sebastián de los Reyes facility;

• €1.0Mn of investment capex related to the ISM® industrialization;

-5

• €0.2Mn of investment capex related to the Escuzar facility; and

• €0.5Mn of maintenance capex and other capex

• €13.5Mn invested in Q1 2019 for the acquisition of Polaramine®.

-10		-19,0		• FCF decreased to €-3.1Mn mainly due to:
				• €13.8Mn increase in capex mainly because of the acquisition of Polaramine® in Q1 19;
-15				• €8.0Mn increase in profit before income tax;
			•	€8.9Mn increase in "trade and other payables" in Q1 2020 vs €1.9Mn increase in Q1
					2019;
-20				• €34.0Mn increase in "inventories" in Q1 2020 vs €13.2Mn increase in Q1 2019;
	Q1 2019	Q1 2020	•	€2.5Mn increase in "trade and other receivables" in Q1 2019 vs €1.7Mn increase in
					Q1 2020.
						19

Financial debt

	Debt breakdown by source (%)			Debt maturities by year (€Mn)
				60
	Total debt		Financial
	€76.7Mn		liabilities for
			leases; 26%
				40
				Bank
				borrowings;					53,4
				59%
	Debt with public	20
	adminsitration;
		15%
								4,5	4,7	4,5	9,6
				0
				2020	2021	2022	2023	2024 onwards

• Debt with public administration represented 15% of total debt, with 0% interest rate.
• Gross cash position of €57.7Mn as of 31 March 2020 vs €68.9Mn as of 31 December 2019.
• Net debt of €19.0Mn as of 31 March 2020 vs €15.9Mn as of 31 December 2019.
• In February 2020, ROVI announced it would pay a dividend of 0.1751 euros per share with dividend rights out of the 2019 profit if the Shareholders General Meeting approved the application of the 2019 profit proposed by ROVI's Board of Directors. This proposed dividend would mean an increase of 119% on the dividend paid out of the 2018 profit (€0.0798/share) and represents a 25% pay-out. As a result of the Covid-19 crisis, ROVI has postponed the General Shareholders Meeting and has placed the dividend proposal under review.

20

News-flow 2020

Specialty

Pharma

Sales of biosimilar of Enoxaparin

Additional new products to be launched

Granting by the competent local authorities of the marketing authorisation of an Enoxaparin biosimilar in 70 countries outside Europe

Toll	New contracts to be announced
manufacturing

Risperidone ISM® expected to be filed in USA in H2 2020

ISM® Risperidone ISM® final Phase III data will be presented in scientific congresses

technology

platform

Next steps of Letrozole ISM® to be discussed with regulatory authorities in 2020

21

For further information, please contact:

Juan López-Belmonte Chief Executive Officer [phone] [e-mail]

Javier López-Belmonte Chief Financial Officer [phone] [e-mail] www.rovi.es

Marta Campos Investor Relations [phone] [e-mail] www.rovi.es