Press Release: Basilea reports strong revenue and profit growth in first half-year 2023

-- Increase in Cresemba(R) and Zevtera(R) related revenue to CHF 80.5

million (+57% year-on-year)

-- Increase in operating profit to CHF 36.9 million and net profit to CHF

31.9 million

-- Increase in cash and restricted cash to CHF 112.9 million

-- Full-year 2023 revenue and profit guidance increased

-- Submitted US NDA for ceftobiprole in August

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, August 15, 2023

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today its financial results for the first half-year ended June 30, 2023.

David Veitch, Chief Executive Officer, stated: "We made very good progress on the implementation of our growth strategy, which is reflected in our strong financial performance, with a 57 percent growth year-on-year in Cresemba and Zevtera related revenue. In early August, we submitted the New Drug Application for ceftobiprole to the US Food and Drug Administration, a key milestone to access the important US market. We are also in discussions with regard to the in-licensing or acquisition of a number of novel, differentiated anti-infective assets, to complement our pipeline and support long-term growth. This makes us confident that we are well on track to become a leading anti-infectives company."

Adesh Kaul, Chief Financial Officer, said: "The first half-year reflected the continued commercial success of our antifungal Cresemba around the world. We reported CHF 30.6 million in milestone payments based on the in-market sales performance from established markets, as well as the start of commercialization in Japan. Royalty income, which more directly reflects the underlying global demand for Cresemba, increased by 27 percent, year-on-year, to CHF 36.7 million. We started to pay back our senior secured loan as planned in the first of half of 2023 and at the same time, also increased our mid-year cash position to CHF 112.9 million. Our financial strength provides us with the ability to add new products to our portfolio, in addition to continuing to grow our business from our existing products."

Financial summary

Basilea recorded total revenue in the first half-year (H1) 2023 of CHF 84.9 million (H1 2022: CHF 57.6 million), which is an increase of 47% year-on-year. Thereof, Cresemba and Zevtera related revenue increased 57% to CHF 80.5 million (H1 2022: CHF 51.2 million). This included royalty income from Cresemba, which increased by 27% to CHF 36.7 million (H1 2022: CHF 28.9 million), and milestone payments of CHF 30.6 million (H1 2022: CHF 2.2 million). Other revenue, amounted to CHF 4.4 million (H1 2022: CHF 6.5 million) and included CHF 2.0 million (H1 2022: CHF 5.0 million) reimbursements from BARDA for the ceftobiprole phase 3 program. The decrease in BARDA reimbursements reflects that the program is ending, as also indicated by our NDA submission.

In H1 2023, research and development expenses decreased by 42% to CHF 21.5 million (H1 2022: CHF 37.1 million). This reflects that we partnered our previous oncology programs by the end of last year, as well as the fact that the ceftobiprole phase 3 program is nearing completion. Selling, general and administrative expenses amounted to CHF 16.5 million (H1 2022: CHF 15.6 million). Cost of products sold amounted to CHF 10.0 million (H1 2022: CHF 14.9 million).

In H1 2023, an operating profit of CHF 36.9 million was recorded (H1 2022: operating loss of CHF 10.0 million) as well as a net profit of CHF 31.8 million (H1 2022: net loss of CHF12.2 million). This resulted in a basic and diluted earnings per share of CHF 2.66 and 2.42, respectively (H1 2022: loss per share of CHF 1.03).

The progress in commercialization led to a significantly improved positive net cash flow provided by operating activities of CHF 21.9 million (H1 2022: CHF 0.15 million). This also resulted in cash and cash equivalents and restricted cash of CHF 112.9 million as of June 30, 2023, hence increased compared to CHF 108.6 million as of December 31, 2022.

Key financial figures

(In CHF million, except per share data) H1 2023 H1 2022

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Product revenue 13.2 19.4

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Contract revenue 67.3 31.8

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Other revenue 4.4 6.5

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Total revenue 84.9 57.6

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Cost of products sold (10.0) (14.9)

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Research & development expenses, net (21.5) (37.1)

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Selling, general & administrative

expenses (16.5) (15.6)

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Total cost and operating expenses (48.0) (67.7)

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Operating profit/loss 36.9 (10.0)

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Net profit/loss 31.8 (12.2)

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Net cash provided by operating activities 21.9 0.15

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Basic earnings/loss per share, in CHF 2.66 (1.03)

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Diluted earnings/loss per share, in CHF 2.42 (1.03)

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(in CHF million) June 30, 2023 Dec 31, 2022

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Cash and cash equivalents and restricted cash 112.9 108.6

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Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently.

The unaudited, condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd, Allschwil for the first half-year 2023 can be found on the company's website at https://www.basilea.com/financial-reports.

Increased full-year 2023 financial guidance

The company increases its financial guidance for the full-year (FY) 2023, excluding the potential impact from any in-licensing or acquisitions:

-- Cresemba & Zevtera related revenue is expected to grow by 20% - 23% toCHF

147 -- 150 million (FY 2022: CHF 122.3 million), reflecting the continued

commercial success of Basilea's marketed products.

-- Operating profit is expected to increase to CHF 50 -- 55 million (FY

2022: CHF 18.5 million) and net profit to CHF 41 -- 46 million (FY 2022:

CHF 12.1 million).

-- The company is planning to continue reducing its debt level through the

partial repayment of the senior secured loan in the amount of

approximately CHF 37 million.

FY 2023e FY 2023e

(in CHF million) (new) (previous) FY 2022

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Cresemba & Zevtera related

revenue 147 to 150 145 to 148 122.3

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Royalty income 76 74 65.0

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Total revenue 157 to 160 155 to 158 147.8

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Cost of products sold 25 to 27 25 to 28 24.6

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Operating expenses 80 80 104.6

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Operating profit 50 to 55 45 to 50 18.5

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Net profit 41 to 46 36 to 41 12.1

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Conference call and webcast

Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, August 15, 2023, at 4 p.m. (CEST), to discuss the company's financial and operating results and to provide an outlook.

Via audio webcast with presentation

The live audio webcast of the results presentation can be followed here: https://media.choruscall.eu/mediaframe/webcast.html?webcastid=W6AYMggN. Please note that there is no function to ask questions via webcast. For questions, please additionally dial-in via phone (see below).

Via phone

To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call.

+41 (0) 58 310 5000 (Europe and RoW)

+1 (1) 866 291 4166 (USA)

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August 15, 2023 01:15 ET (05:15 GMT)