Investor Presentation • Dec 14, 2017
Investor Presentation
Open in ViewerOpens in native device viewer
14th December 2017 Richard Godfrey, CEO
Certain statements contained in this presentation constitute forwardlooking statements. Forward-looking statements are statements that are not historical facts and they can be identified by the use of forward-looking terminology, including the words "anticipate", "believe", "intend", "estimate", "expect", "will", "may", "should" and words of similar meaning. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. Accordingly, no assurance is given that such forwardlooking statements will prove to have been correct. They speak only as at the date of the presentation and no representation or warranty, expressed or implied, is made by BerGenBio ASA or its affiliates ("BerGenBio"), or by any of their respective members, directors, officers or employees that any of these forward-looking statements
or forecasts will come to pass or that any forecast result will be achieved and you are cautioned not to place any undue influence on any forward-looking statement. BerGenBio is making no representation or warranty, expressed or implied, as to the accuracy, reliability or completeness of this presentation, and neither BerGenBio nor any of its directors, officers or employees will have any liability to you or any other person resulting from the use of this presentation.
Copyright of all published material, including photographs, drawings and images in this presentation remain with BerGenBio and relevant third parties, as appropriate. Consequently, no reproduction in any form of the presentation, or parts thereof, is permitted without the prior written permission, and only with appropriate acknowledgements.
Leaders in developing therapeutics
that target AXL, a protein that makes cancers and their environment highly aggressive and which is associated with poorer outcomes across many cancers
Diversified pipeline, lead drug is tested in several indications of high unmet medical need and large market potential
Promising efficacy with sustained treatment benefit and confirmed favourable safety
Companion diagnostic supported by biomarker tests
First-in-class highly selective small molecule AXL inhibitor
Broad phase II clinical programme in NSCLC, TNBC, AML/MDS, melanoma
Pipeline
BGB324
AXL antibody
AXL ADC (partnered)
Immunomodulatory small molecules
OSE:BGBIO
Raised NOK400m in IPO on OSE in April '17
NOK1,000m market cap (Dec13th 2017)
35 staff
Headquarters and research in Bergen, Norway; Clinical Trial Management in Oxford, UK
8
| BerGenBio BGB324 19% 37 patients all comers, elderly R/R patients |
|
|---|---|
| et al1 Pratz TAK-659 9% 31 patients investigational FLT-3 and SYK inhibitor |
|
| et al4 Daver FLX925 0% 51 patients Dual FLT3 and CDK4/6 Single agent |
|
| Dawson et al6 GSK525762 11% 46 patients BET inhibitor |
|
| et al5 DiNardo Ivosidenib (AG-120) 258 patients – selected mutant IDH1 (mIDH1) inhibitor 30% for mlDH1 mutation |
|
| Goldberg et al2 24 patients Venetoclax* + hypomethylating agent (HMA) or low dose 28% cytarabine (LDAC) Combination |
|
| Rausch et al3 27 patients Venetoclax + HMA or LDAC 22% |
*Venetoclax + LDAC received breakthrough designation in 1st line AML (July 2017)
9 (1) ASH 2017 abstract 2622 (2) ASH 2017 abstract 1353 (3) ASH 2017 abstract 1356 (4) ASH 2017 abstract 1343 (5) ASH 2017 abstract 725 (6) ASH 2017 abstract 1377
19% Response Rate (CRi + PR)
• 2 CRi
• 5 PRs
An additional 7 patients were stable > 4 months
Correlation with predictive biomarker candidates
BGBC003 Phase II – AML/high risk MDS as monotherapy and in combination with decitabine or azacitidine
BGBIL005 – patient population
Best response (CT scan every 6 weeks)
| Age, ethnicity & sex |
63 year old Caucasian female |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung, lymph, lung metastasis |
| Mutations | None (EGFR wt, ALK negative) |
| Previous lines of therapy |
CARBOPLATIN/PACLITAXEL CARBOPLATIN/PEMETREXED PEMBROLIZUMAB |
| Current status | Ongoing, C5 |
| Age, ethnicity & sex |
53 year old Asian male |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung, lymph, liver, brain |
| Mutations | None (EGFR wt, ALK negative) |
| Previous lines of therapy |
CISPLATIN/PEMETREXED CISPLATIN VINORELBINE NIVOLUMAB |
| Current status | Ongoing, C5 |
| Age, ethnicity & sex |
75 year old Caucasian male |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung, lymph |
| Mutations | CAM5.2, MIB-1 |
| Previous lines of therapy |
CARBOPLATIN/PACLITAXEL/BEVACIZUMAB PEMETREXED NIVOLUMAB |
| Current status | Off study, alive |
| Age, ethnicity & sex |
63 year old Hispanic male |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung |
| Mutations | None (EGFR wt, ALK negative) |
| Previous lines of therapy |
NIVOLUMAB/IPILIMUMAB NIVOLUMAB CARBOPLATIN/PEMETREXED |
| Current status | Off study, alive |
BGBIL005 Phase I/II – NSCLC (2nd line – progressed/treatment-refractory disease) – Investigator-sponsored study
"The vast majority of my lung cancer patients progress onto chemotherapy, combining this with BGB324 may significantly improve the performance of the chemo and could lead to meaningful disease modification in some patients."
Time after diagnosis (years)
| Astrocytic brain tumors | Melanoma |
|---|---|
| Breast cancer | Mesothelioma |
| Gallbladder cancer | NSCLC |
| GI | Pancreatic cancer |
| • Colon cancer |
Sarcomas |
| • Esophageal cancer |
• Ewing Sarcoma |
| • Gastric cancer |
• Kaposis sarcoma |
| Gynaecological | • Liposarcoma |
| • Ovarian cancer |
• Osteosarcoma |
| • Uterine cancer |
Skin SCC |
| HCC | Thyroid cancer |
| HNC | Urological |
| Haematological | • Bladder cancer |
| • AML |
• Prostate cancer |
| • CLL |
• RCC |
| • CML |
AXL low = Higher survival; AXL high = Poor survival
Companion diagnostic in development to identify AXL positive patients
Significant value drivers expected over the next 12 months:
üInterim clinical data from 6 ph2 trials H1'18
üFinal readout from 4 phase 2 trials in H2
üInitiation of AXL antibody BGB149 clinical trials in H2
| Key Figures (NOK million) | Q3 2017 | Q3 2016 | YTD2017 | YTD2016 | FY 2016 |
|---|---|---|---|---|---|
| Operating revenues | |||||
| Operating expenses | - 36.6 |
- 16.3 |
- 136.2 |
- 103.5 |
- 131.6 |
| Operating profit (loss) | -36.6 | -16.3 | -136.2 | -103.5 | -131.6 |
| Profit (loss) after tax | -35.4 | -15.4 | -134.6 | -101.9 | -129.8 |
| Basic and diluted earnings (loss) per share (NOK) |
-0.71 | -45.64 | -3.06 | -339.63 | -419.68 |
| Net cash flow in the period | -41.1 | 82.1 | 237.3 | 113.2 | 87.8 |
| Cash position end of period | 399.2 | 187.2 | 399.2 | 187.2 | 161.8 |
• OPEX sequentially increased by 8% in Q317 over Q217 as recruitment to our clinical studies is ramping up
• Robust cash position gives runway to deliver key clinical read outs on our ongoing clinical studies.
First-in-class AXL inhibitors for aggressive cancers with addressable market in excess of \$11bn
BGB324 in multiple Phase II programmes with interim data readout @ ASCO 2018
Well resourced & experienced organisation to deliver pipeline and milestones
Clear strategy to develop and commercialise assets
Developing first-in-class Axl inhibitors to treat aggressive cancer
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.