Pharma Mar S A : 1Q2021

REPORT AT 31 MARCH 2021

5 May 2021

1Q21 MILESTONES

Corporate

• Group net revenues amounted to €34.4 million, 39% more than in the first quarter of 2020 (€24.9 million).
• Royalties from sales of Yondelis and Lurbinectedin by our partners in their respective territories amounted to €8.7 million, up from €0.7 million in the year-ago quarter.
• Licensing revenues totaled €8.1 million, from the licensing agreement for Zepzelca signed with Jazz
  Pharmaceuticals in 2019 (€73.9 million in the year-ago quarter).
• Group revenues amounted to €51.3 million in the first quarter of 2021 (€99.5 million in the year-ago quarter).
• Net cash balance increased €17.2 million in the first quarter.
• Rating agency Axesor upgraded PharmaMar's long-term rating by two notches from "BB-", outlook positive, to "BB+", outlook stable.

Oncology

• At the International Association for the Study of Lung Cancer (IASCL) meeting, PharmaMar presented data from the Phase Ib/II trial with Zepzelca in combination with irinotecan in small cell lung cancer.
• PharmaMar signed a licensing agreement with ADIUM for marketing lurbinectedin in Latin America.
• The Therapeutic Goods Administration (TGA), which is the Australian regulator, approved Yondelis for treating patients with liposarcoma or leiomyosarcoma.

Diagnostics

• Genómica's qCOVID-19 Respiratory COMBO kit has been validated for use with direct saliva samples.

RNAi

• The US Food and Drug Administration (FDA) authorized the commencement of a Phase III clinical trial with SYL1001 to treat dry eye disease associated with Sjögren's syndrome.

Mª Luisa de Francia	José Luis Moreno
CFO	Head of Capital Markets and Investor Relations
PHARMA MAR, S.A.	PHARMA MAR, S.A.
Plaza Descubridor Diego de Ordás, 3	Plaza Descubridor Diego de Ordás, 3
Madrid	Madrid
Telephone [phone]	Telephone [phone]

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FIGURES TO MARCH 2021

		03/31/2021	03/31/2020	Var.
	Oncology Sales	33.201	22.898	45%
	Commercial Sales	27.287	20.541	33%
	API & vials sales	5.914	2.357	151%
	Diagnostics Sales	1.212	1.903	-36%
	Sales	34.413	24.801	39%
	Royalties	8.671	665	1204%
	Licences	8.140	73.923
	Other	37	64	-42%
	TOTAL REVENUES	51.261	99.453	-48%
	Thousand euro

Group revenues:

Group net revenues amounted to €34.4 million in the first quarter of 2021, up 39% on the year-ago quarter (€24.8 million). This increase was due to good performance of oncology sales, where Yondelis sales reached €18.9 million in the first quarter, up from €18.4 million in the first quarter of 2020 (+3%). Sales of Zepzelca in Europe (under the Temporary Authorisation for Use) also increased, to €8.4 million, in the first quarter of 2021 (+288% year-on-year).Sales of the Yondelis and Zepzelca API to partners amounted to €5.9 million in the first quarter (up +151% on the €2.4 million registered in the year-ago quarter). Diagnostic sales were affected by lower demand for COVID-19 diagnostic tests due to stockpiling by the healthcare administrations in previous quarters, while conventional sales have not yet returned to normal due to the lower level of hospital activity in our traditional diagnostics area; as a result, this item declined by €0.7 million compared with the first quarter of 2020.

Oncology sales

18,4	18,9
				8,4	5,9
		2,2				2,4
Yondelis sales UE		Zepzelca sales UE	API sales
			(ATU)
			March 20			March 21

Royalties revenues amounted to €8.7 million in the first quarter of 2021, up from €0.7 million in the year-ago quarter. That figure includes royalties from Yondelis sales by our partners in the United States and Japan (€0.7 million) and from Zepzelca sales by our US partner Jazz Pharmaceuticals (€8 million in the first quarter).

Licensing revenues amounted to €8.1 million in the first quarter of 2021, compared with €73.9 million in the year-ago quarter. In both cases, those figures relate to Zepzelca under the agreement with Jazz Pharmaceuticals, revenues from which are recognized in the P&L as a function of the degree of progress with the contractual commitments.

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R&D

Group net R&D spending increased by 19.6% year-on-year to €14.7 million in the first quarter of 2021 (€12.3 million in the year-ago quarter).

Oncology invested €13 million in the first quarter of 2021, including €2.2 million of costs incurred in clinical trials to develop plitidepsin (Aplidin) for the treatment of COVID-19. The Oncology area made progress with trials of lurbinectedin in combination with other therapeutic agents, and in the design of Phase III trials for indications other than small cell lung cancer.

The RNA interference segment increased capital expenditure to €1.5 million in the first quarter, reflecting preparatory work for the Phase III trial in the US with tivanisiran on dry eye disease associated with Sjögren's syndrome as well as the necessary expenditure to commence the Phase I trial in Spain with SYL18001 in macular degeneration.

The breakdown of R&D expenditure is shown in the next table:

	03/31/2021	03/31/2020	Difference
R&D expenses	14.703	12.289	2.414	19,6%
Oncology	12.972	11.477	1.495	13,0%
Diagnostics	241	141	100	70,9%
RNAi	1.490	671	819	122,1%
(Thousand euro)

Other operating expenses

Other operating, commercial, administrative and corporate expenses amounted to €12.9 million in the first quarter of 2021, a reduction of 12.5% with respect to the year-ago quarter (€14.8 million). This decline was mainly due to corporate expenses incurred last year in connection with the licensing agreement with Jazz Pharmaceuticals.

EBITDA

Group EBITDA amounted to €19.4 million in the first quarter of 2021 (€72.6 million in the year-ago quarter).

	3/31/21	3/31/20
Net Result	24.181	70.567
Income tax	(2.302)	338
Net financial income	(3.773)	(405)
Depreciation and amortization	1.327	2.052
EBITDA	19.433	72.552
(Thousand euro)

(EBITDA: earnings before interest, taxes, depreciation and amortization).

The variation in EBITDA reflects the lower amount of revenues recognized from licensing agreements (€65.8 million less than in the year-ago quarter), which was partly offset by higher sales and royalties (€17.6 million more than in the year- ago quarter). Overall, operating expenses (including R&D) remained stable.

Cash and Debt

As of 31 March 2021, cash and cash equivalents plus current financial assets and non-current financial assets amounted to €231 million (vs. €216.5 million at 2020 year-end).

Total interest-bearing debt was reduced by €2.7 million in the first quarter.

As a result, net cash flow in the first quarter amounted to €17.2 million.

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For the purpose of comparing balance sheet figures, the Group's total position in cash and (net interest-bearing debt) at amortized cost is detailed below:

	31/03/2021	31/12/2020	Var.
Non current debt	34.132	37.732	-3.600
Bank debt	2.278	3.561	-1.283
Obligations and bonds	16.613	16.600	13
Govt. Agencies: R&D funding	15.241	17.571	-2.330
Current debt	16.235	15.313	922
Credit facilities	4.585	4.771	-186
Effects and certifications	788	0	788
Bank loan	5.138	5.487	-349
Govt. Agencies: R&D funding	5.085	4.621	464
Interest and others	639	434	205

Total financial debt

Cash&cash equivalents + non current and current financial investment

TOTAL NET CASH

(Thousand euro)

50.367	53.045	-2.678
230.988	216.504	14.484
180.621	163.459	17.162

BUSINESS PERFORMANCE.

Below is an overview of research and development activities in the first quarter of 2021.

1.- Oncology segment: PharmaMar Compounds:

A) Trabectedin (YONDELIS)

Soft tissue sarcoma

In the first quarter of 2021, 25 post-authorization trials were under way, 15 of them active (8 enrolling new patients). The other trials were in the process of closing or data analysis or were pending the presentation of results. Four additional trials are scheduled to commence in the coming months.

The preliminary results from the cohort of non-Lsoft-tissue sarcoma patients in the NiTraSarc Phase II trial to assess the efficacy of the combination of nivolumab with trabectedin will be presented at the ASCO meeting, which is scheduled for June 4-8 2021.

Ovarian cancer

There were a total of 13 trials in this indication: 7 were active, 2 were in the process of closing, and 2 were in the activation phase.

Other indications

Enrolment continued for the TOP-ART trial, which combines trabectedin and olaparib in treating solid tumors with DNA repair defects.

1. Lurbinectedin (ZEPZELCA )Small-cell lung cancer

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Contacts have been initiated with the regulators with a view to commencing a Phase III trial in small cell lung cancer aimed at obtaining full approval in the US and approval in Europe.

Additionally, the regulatory processing of the registration dossier for Zepzelca in this indication is advancing in several countries.

Combination trials with Zepzelca (lurbinectedin)

Recruitment continues on schedule for the Phase I trial in combination with irinotecan, pembrolizumab and atezolizumab.

Combination trial with irinotecan:

PharmaMar presented the data from the trial with Zepzelca in combination with irinotecan in an oral session at the IASLC World Conference on Lung Cancer (IASLC WCLC), held on January 28-31 2021. The combination of lurbinectedin with irinotecan proved to be effective in patients with small cell lung cancer who had relapsed after first-line treatment, showing considerable activity in patients with resistant disease.

Data were presented from a total of 21 evaluable patients with small cell lung cancer who had experienced progression after receiving at least one line of platinum-based chemotherapy. The Objective Response Rate (ORR) was 62%, with median Progression-Free Survival (PFS) of 6.2 months. The combination was found to have a manageable safety profile.

Phase I trial in China

The Phase I trial, being conducted by our partner Luye and designed to ascertain the dose of Zepsyre® in Chinese patients, is recruiting satisfactorily.

1. Virology Unit: Plitidepsin (APLIDIN®)Aplidin (plitidepsin)

The clinical report on the results from the APLICOV-PCproof-of-concept clinical trial with Aplidin® (plitidepsin) for treating adult patients with COVID-19 who required hospitalization is ready and will be sent to the agencies shortly; the goal is to accompany it with a publication in a peer reviewed journal.

In January 2021, Science published a research article confirming plitidepsin's strong efficacy against SARS-CoV-2 in a preclinical setting.

With regard to the multicenter, randomized, controlled Phase III clinical trial to determine the efficacy and safety of two dosages of plitidepsin versus control in adult patients requiring hospitalization for the treatment of moderate COVID- 19 infection, we have decided to prioritize the trial in Europe, given that the proof-of-concept study was conducted in Spain. The NEPTUNE trial currently being initiated in Europe will also be extended to Latin America. We have already responded favorably to the most recent package of requests for clarification received via the European centralized procedure and, consequently, expect to complete the local administrative processes shortly with a view to beginning to recruit patients as soon as possible.

Progress is also being made with the design of a new Phase I/II protocol to assess the safety and reduction of the viral load achieved with a line of treatment with plitidepsin in adult patients with COVID-19 who are discharged from emergency departments.

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