Galapagos: Strong clinical progress in H1 and transformative collaboration with Gilead announced

 

Galapagos NV (Euronext & NASDAQ: GLPG) announces its unaudited first half-year results, which are further detailed in its H1 2019 report available on the Galapagos website, www.glpg.com.

 

"It's our 20th anniversary year, and what a year so far," said Onno van de Stolpe, CEO. "Our partner Gilead and we announced a transformational global R&D collaboration on 14 July, securing our company's independent R&D for years to come. This agreement is about maximizing innovation based on the identification and development of new mode of action medicines. In Q1 2019, together with Gilead, we announced positive data from the first 24 weeks of the FINCH 1 and 3 Phase 3 trials in rheumatoid arthritis, bringing our total patient exposure to filgotinib to beyond 3,000 patient years. The FINCH trial safety data was consistent with the long-term safety data observed in the DARWIN 3 long term extension trial, further strengthening our understanding of the potential impact of selective JAK1 inhibition on patient well-being. Our research engine continues to be extremely productive, with additional late stage trial starts, completion of recruitment in ROCCELLA, and our first Phase 1 trial from the next-generation Toledo program for inflammation."

 

"Our financial guidance for full year 2019 operational cash burn[1] between €320 and €340 million is unchanged, excluding the proceeds from the recent deal announced with Gilead. Upon closing, which is expected before the end of 2019, we are entitled to an upfront payment of $3.95 billion and a $1.1 billion equity investment by our collaboration partner Gilead", said Bart Filius, CFO and COO of Galapagos.

 

 

Outlook 2019

Following  the positive Phase 3 FINCH trial results, Gilead discussed submissions for approval of filgotinib in RA with regulatory authorities in 2019. Early July, Gilead announced that following a meeting with the U.S. FDA, a path forward for filing filgotinib in RA in 2019 has been established. Gilead intends to file filgotinib for approval in RA in Europe in Q3 2019. They also anticipate readouts from the proof-of-concept trials in Sjögren's syndrome and cutaneous lupus, and plan to launch a Phase 3 trial in psoriatic arthritis.

 

We will continue recruitment in our proprietary ISABELA and NOVESA trials with GLPG1690, and plan to finish recruitment of our PINTA trial with GLPG1205. For MOR106, together with our collaboration partners MorphoSys and Novartis, we plan to continue executing the ongoing Phase 1 and 2 trials.

 

With regard to our earlier and fully proprietary programs, we expect the Phase 1 readout of GLPG3312, our first Toledo compound, with a Phase 1 for a second Toledo compound (GLPG3970), scheduled for the second half of the year.

 

The Gilead transaction, which is expected to close late in the third quarter of 2019, is subject to certain closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

 

Upon closing, we are entitled to an upfront payment of $3.95 billion in addition to a $1.1 billion equity investment.

 

Key figures first half-year report 2019 (unaudited)

(€ millions, except basic & diluted loss per share)

 

 

30 June 2019 group total

30 June 2018 group total

Revenues

108.5

101.9

R&D expenditure

(177.6)

(151.4)

G&A and S&M expenses

(28.5)

(16.2)

Operating loss

(97.6)

(65.8)

 

 

 

Net financial result

1.8

6.9

Taxes

(0.1)

(0.1)

Net result for the period

(95.9)

(59.1)

Basic and diluted loss per share (€)

(1.76)

(1.16)

 

 

 

Cash and cash equivalents

1,147.9

1,066.8

 

 

 

First half-year report 2019

Galapagos' financial report for the first half-year ended 30 June 2019 can be accessed via www.glpg.com/financial-reports.

 

Conference call and webcast presentation

Galapagos will conduct a conference call open to the public tomorrow, 26 July 2019 at 14:00 CET / 8 AM ET, which will also be webcast. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

 

CODE: 6080337

 

USA:

+1 323 794 2423

UK:

+44 330 336 9105

Netherlands:

+31 20 721 9251

France:

+33 1 76 77 2274

Belgium:

+32 2 404 0659

 

A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

 

Financial calendar

24 October 2019           Third quarter 2019 results (webcast 25 October 2019)

20 February 2020          Full year 2019 results (webcast 21 February 2020)

 

Filgotinib and all other drug candidates mentioned in this report are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

 

Note

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

 

 

Interested in a regular update of the Life Sciences and biotech sector in Flanders?