Press Release: Basilea reports strong financial -2-

grow to CHF 77-87 million (+12% to +27% y-o-y), reflecting the continued

significant growth of in-market sales by our partners.

-- Total R&D and SG&A expenses are expected to remain approximately stable.

Cost of products sold is expected to increase based on higher product

deliveries to partners. An anticipated extension of the supply period to

Pfizer is expected to positively affect revenue and increase cost of

products sold, primarily in 2021.

-- The anticipated operating loss amounts to CHF 5-15 million.

-- Cash and short- and long-term investments are expected to be

approximately CHF 150 million at year-end 2020. This represents a

significant increase compared to the initial guidance, due to the

proceeds from the headquarters property sale and the convertible bond

transactions and being partially offset by a temporary increase in

working capital, which is anticipated to be reversed in early-2021.

FY 2020e FY 2020e

(In CHF million) (updated) (initial) FY 2019a

------------------------------------------ ----------- ----------- --------

Cresemba & Zevtera revenue

(non-deferred) 77-87 77-87 68.7

------------------------------------------ ----------- ----------- --------

Cresemba & Zevtera revenue

(deferred) 33 33 45.6

------------------------------------------ ----------- ----------- --------

Other (mostly BARDA reimbursements) 17-18 18 20.0

------------------------------------------ ----------- ----------- --------

Total revenue 128-138 128-138 134.4

----------- ----------- --------

Cost of products sold 23 25 18.9

------------------------------------------ ----------- ----------- --------

R&D and SG&A 135 133 132.7

------------------------------------------ ----------- ----------- --------

Profit from sale of assets 15 0 0

------------------------------------------ ----------- ----------- --------

Operating loss 5-15 20-30 17.2

----------- ----------- --------

Cash and short- and long-term investments

(year-end) 150 100-110 161.0

------------------------------------------ ----------- ----------- --------

Portfolio -- Continued commercial success of our anti-infective brands

and important upcoming milestones for our oncology drug candidates

Cresemba in-market sales continue to grow

Cresemba has reached USD 220 million "in-market sales" for the 12 months

to the end of March 2020, which is a more than 30% growth

year-on-year.(2) Our partners have reported a number of additional

approvals and launches in territories around the world since the

beginning of the year. This includes launches in key markets in Asia

Pacific and approval in Russia. These triggered commercial and

regulatory milestone payments of approximately CHF 6 million from Pfizer

to Basilea. To date, Cresemba has been launched in 45 countries and

marketing application processes have been initiated in a number of

additional countries, including in China, where the Marketing

Authorization Application for mucormycosis was recently accepted for

regulatory review by the health authority. We therefore remain confident

that our partners will have launched Cresemba in 60 countries by the end

of 2021.

Zevtera (ceftobiprole) SAB phase 3 study now expanded to enrol more

difficult-to-treat patients

The U.S. Food and Drug Administration (FDA) approved the amendment of

the protocol for the phase 3 study ERADICATE, which is conducted in

patients with Staphylococcus aureus bacteremia (SAB).(3) This amendment

extends the maximum treatment duration from four, to now up to six weeks,

which allows for the inclusion of patients with more difficult-to-treat

infections, including those with complications such as osteomyelitis and

epidural or cerebral abscess. We expect that the recruitment of the

ERADICATE study can be completed in H2 2021. If the study is positive,

as reported for the TARGET phase 3 study last year, which evaluated

ceftobiprole in the treatment of patients with acute bacterial skin and

skin structure infections, Basilea plans to submit a New Drug

Application (NDA) to the FDA.(4) As ceftobiprole was designated a

Qualified Infectious Disease Product (QIDP) by the FDA for these

indications, if approved, ceftobiprole will be eligible to receive ten

years of market exclusivity in the U.S. from the date of approval.

Key oncology clinical studies with derazantinib and lisavanbulin remain

on track

In July, we announced that the patient enrolment into the first cohort

of the FIDES-01 study with the FRGR kinase inhibitor, derazantinib, has

been completed.(5) This first cohort enroled patients with advanced

intrahepatic cholangiocarcinoma (iCCA), a type of bile duct cancer,

whose tumors expressed fusions of the FGFR2 gene, a genetic aberration

which has previously been identified as driving this type of cancer. A

second cohort, which enrols iCCA patients with other FGFR2 genetic

aberrations, namely mutations and amplifications, is ongoing with

interim results expected during H2 2020. The results from the second

cohort will support defining the full therapeutic potential of

derazantinib in iCCA and potentially further strengthen the

differentiation of derazantinib from other FGFR kinase inhibitors. In

addition, the clinical development program for derazantinib includes two

further Phase 1b/2 studies, the ongoing FIDES-02 in patients with

urothelial cancer and the planned FIDES-03, in patients with advanced

gastric cancer, which is expected to start in Q3 2020.(6) In FIDES-02

and FIDES-03, we are not only exploring derazantinib as a single agent,

but also in combination with an immuno-oncology drug, atezolizumab

(Tecentriq(R) ), with the rationale that derazantinib may enhance the

response to immuno-oncology treatment.(7)

In 2019, initial results of a phase 1 study with daily oral lisavanbulin

in patients with glioblastoma multiforme (GBM), the most common type of

primary brain cancer and one of the most lethal types of cancer, have

been reported.(8) These results showed clinical activity of lisavanbulin

in GBM with one exceptional, long-lasting responder, whose brain tumor

tissue displayed strong expression of the protein EB1. Full results of

the study as well as data on the potential utility of EB1 as a

response-predictive biomarker for lisavanbulin have been accepted for

presentation at this year's annual congress of the European Society of

Medical Oncology (ESMO) which is taking place in a virtual format in

September 2020. Based on the results of this and other studies, we have

decided to progress lisavanbulin to the next clinical stage and are

preparing a biomarker-driven phase 2 study with lisavanbulin in patients

with GBM. The start of the study is anticipated in the next few months.

We expect interim results for this study in H1 2021 and top line results

in H2 2021. This approach allows us to efficiently test our hypothesis

that lisavanbulin can be developed in a targeted patient population,

initially in GBM and then potentially in other tumor types.

Conference call and webcast

Basilea Pharmaceutica Ltd. will host a conference call and webcast today,

Tuesday, August 11, 2020, at 4 p.m. (CEST), to discuss the Company's

financial and operating results.

Via audio webcast with presentation

The live audio webcast of the results presentation can be followed here

https://www.globenewswire.com/Tracker?data=xLyarSWnFcEbeurMvF95sevj8SVu4vR6upqtGKgSmBZLCBjZpHxAaArDKmph7durVuJHNZpOCpNkL8RgCNkuCew5gSQ60ShvdR3URmU_bY6dmFoR4YnN8ZjLScgg6b5fqVySfLgBxL_m2vGhkPfr5oZsP9qVcUrgRGZsr2kb_TA=

. 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)

+44 (0) 207 107 0613 (U.K.)

Replay

The webcast, along with presentation will be available online

https://www.globenewswire.com/Tracker?data=aY5tmr0CxqDxiHu6o5e1kOFrZhH_JCctAP-M0lqPnaombUGIq9RTEyeG3AAmQjF5wOiMdDsqJDds2U5V_KCgss8KK8fla_GzP2w5OQ2-UsYPyTiQ2cWvDitXTJ4C_6bms624b8AZkrFos0P7eZXPSPLn-1E1-g-aW4ABF7ghQ4Y=

shortly after the event and accessible for three months.

About Basilea

Basilea Pharmaceutica Ltd. is a commercial-stage biopharmaceutical

company, focused on the development of products that address the medical

challenges in the therapeutic areas of oncology and infectious diseases.

With two commercialized drugs, the company is committed to discovering,

developing and commercializing innovative pharmaceutical products to

meet the medical needs of patients with serious and life-threatening

conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel,

Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional

information can be found at Basilea's website www.basilea.com.

Disclaimer

This communication expressly or implicitly contains certain

forward-looking statements, such as "believe", "assume", "expect",

"forecast", "project", "may", "could", "might", "will" or similar

expressions concerning Basilea Pharmaceutica Ltd. and its business,

including with respect to the progress, timing and completion of

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August 11, 2020 01:15 ET (05:15 GMT)