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ArcticZymes Technologies — AGM Information 2017
May 11, 2017
3538_iss_2017-05-11_883691a3-7c9f-447a-98cd-b54cb8eaec36.pdf
AGM Information
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Presentation by the management on the status of the Group AGM 2017
11.05.2017
Agenda
- Highlights
- Financial highlights
- Beta-Glucans
- Enzymes
- Outlook
Highlights for 2016 and Q1 2017
- 30% Revenue growth in 2016 to NOK 78.6M (60.5)
- Started commercial sale of Woulgan in Germany and Nordic markets
- Strong clinical feedback from UK focus groups
- UK Drug Tariff rejected Woulgan for reimbursement in May 2017
- Cleared in arbitration for Nutrition leave opportunity to sell these products world wide
- Strong growth in demand for Feed ingredient in 2016 and into 2017
- Promising development in the cancer area. Study at MSKCC expanded population from 115 to 145 patients
- ArcticZymes launched 6 new products in 2016
- ArcticZymes 22% revenue growth and MNOK 3.9 in 2016 EBITDA
Financial highlights 2016 and Q1 2017
| NOK million | Q1 2017 | Q1 2016 | 2016 | 2015 |
|---|---|---|---|---|
| Sales Enzymes | 8.9 | 8.1 | 28.7 | 23.5 |
| Sales BetaGlucans | 9.3 | 9.2 | 43.2 | 29.7 |
| Other revenues | 1.6 | 1.9 | 6.7 | 7.3 |
| Total revenues |
19.8 | 19.2 | 78.6 | 60.5 |
| Enzymes | 2.6 | 2.6 | 3.8 | 3.1 |
| BetaGlucans | -4.6 | -4.2 | -17.1 | -8.5 |
| Corporate unallocated | -2.1 | -1.9 | -5.8 | -9.1 |
| EBITDA | -4.1 | -3.5 | -19.0 | -14.4 |
| EBIT | -4.6 | -3.9 | -21.0 | -17.3 |
Cash flow 2016 and Q1 2017
| NOK million | Q1 2017 | Q1 2016 | 2016 | 2015 |
|---|---|---|---|---|
| Operating activities | -9.8 | -10.7 | -19.3 | -12.9 |
| Investing activities |
-1.4 | 0 | -1.3 | -1.5 |
| Financing activities |
0 | 0 | 0 | 4.4 |
| Changes in cash and cash equivalent |
-11.2 | -10.7 | -20.7 | -9.9 |
| Cash and cash equivalents at the beginning of period |
57.7 | 78.3 | 78.3 | 88.3 |
| Cash and cash equivalents at the end of period |
46.5 | 67.7 | 57.7 | 78.3 |
Beta-Glucans
Beta-Glucan product portfolio
Woulgan®
Woulgan® positioning
- Positioned towards stalled wounds, meaning wounds not closed by 40% after 4 weeks of standard card
- Defined as a premium priced product no comparative gel products with an active substance
- A new product with a unique mode of actions
- Obtained very strong claims when approved in EU
2016 Woulgan® summary
| Nordics | Germany | UK | |
|---|---|---|---|
| Go-to-market: | Navamedic increased Woulgan headcount to 9 heads |
Trained 12 distributor reps and 30 key account wound care nurses |
Distributor hired Woulgan Sales Specialist |
| Market access |
Woulgan listed on 3 tenders | Reimbursed by multiple sick funds in several regions |
Gained listing on NHS Supply Chain Framework for Acute hospitals |
| Clinical practice | Participated 10 congresses 2 Publications |
Participated 4 congresses | Participated 6 congresses 10 Posters |
| Market metrics | 130 clinicians tested Woulgan in 80 sites |
30 clinicians tested Woulgan |
35 clinicians tested Woulgan in 30 sites |
| 2,000 tubes sampled |
2,000 tubes sampled |
1,200 tubes sampled | |
| 2,560 tubes purchased | 3,350 tubes purchased | ||
| About 300 patients treated |
About 250 patients treated | About 120 patients treated | |
10
UK Drug Tariff process
- Mail received May 2nd 2017 from DT where the application was rejected because they consider the evidence provided to be insufficient to document cost effectiveness
- The short term effect is that the sales growth we had planned for in the UK market will be delayed. There are no effect on other markets
- Going forward we will focus on two parallel processes:
- Consider an appeal according to NHS guidelines
- Prepare for a new submission when we have concluded on further studies that are either ongoing or about start. Potential timing Q1 2018
Other Highlights UK
- •Confirmed Woulgan to be listed on NHS Supply Chain for hospitals & some off -Drug Tariff community trusts
- •Will generate some sales
- •UK case series published in Journal of Wound Care in Feb. 2017. Two additional published March and May 17
Highlights Germany
- Repeated homecare company (HCC) sales
- Several other HCC's in process
- Hosted German advisory board
- Recruited several KOLs to participate in case evaluation series
- A 40 patient VLU case study in process
- Woulgan added into wound specialist training centres in Germany
Highlights Nordics
- •Sales growing
- Running many evaluations at county level in all countries
- Active at wound congresses (Sweden, Finland and Norway)
- Recruitment to the Nordic evaluation series started. Promising results so far
Woulgan (2% SBG) – clinical documentation
| Studiedesign | Indikasjon | Antall pasienter |
Alder på sår | Hovedfunn | Referanse |
|---|---|---|---|---|---|
| Randomisert, placebokontrollert |
Diabetiske legg og fotsår |
60 | >4 uker |
44% vs 17% full tilheling etter 8 uker 59% vs 37% full tilheling etter 12 uker. |
Zykova et al 2014. J Diabet Invest 5. |
| Randomisert, placebokontrollert |
Diabetiske fotsår (DFU) |
42 (122) | >4 uker | 52% vs 33% full tilheling etter 8 uker (subanalyse) |
Haider et al. 2010 LINK rapport |
| Case-serie UK | (Venøse) leggsår (22) DFU |
26 | 50 uker (gj. snitt) |
27% full tilheling etter 12 uker, 38% etter 20 uker |
King et al 2017 J Wound Care 26 |
| Evalueringsstudie UK | (V)LU & DFU | 16 | >6 uker | 93% veldig god tilheling |
Joy 2014. Wounds UK |
| Evalueringsstudie N | Ulike kroniske sår (LU, PU, DFU m.m.) |
58 | >4 uker | 72% god til særdeles god tilheling |
Engstad & Skjæveland 2015 EWMA, London |
| Case-studier EU |
Ulike kroniske sår | >13 | >4 uker | God tilheling – flertall full tilheling |
Woulgan .com; EWMA; Wounds UK; NIFS |
| Randomisert, kontrollert PMCF |
DFU | 80 | > 4 uker | Pågår (UK & Sverige) | |
| Case-serie | Ulike kroniske sår | Ca 100 |
>4 uker | Pågår (Tyskland, Sverige & Norge) |
15
Woulgan® in other markets
- •US Product registered in "claimless" preliminary class. Focus on:
- •Clinical and registration strategy to obtain favourable reimbursement
- •Partner process
- •Australia Applied for registration
- •Canada Under evaluation
- •Asia Process started
- Some additional European markets under considerations
Other Beta-Glucan areas
M -Gard ® - Nutrition product
- Cleared in arbitration means right to sell products world wide
- Utilize production capacity in existing facilities = about NOK 20M revenue potential
- A number of commercial activities within consumer health generating leads and opportunities
- Strategy to sell directly to production and trade mark owners makes us very competitive
- Will launch a web -shop for sales of M -Gard® to consumers in 2017
M-Glucan®- Animal health
- Experienced solid growth in demand from 2015 to 2016 and into Q1 2017
- Close to production capacity of supplier. Collaborating to expand production capacity to meet expected further increase
- May 2016, signed an additional 2 year supply agreement with an indicated value of MNOK 20
Cancer adjuvant
- Memorial Sloan Kettering Cancer Center (MSKCC) expand their Neuroblastoma study to 145 patients due to positive results. 120 patients are enrolled
- MSKCC plan to publish results in the second half of 2017
- Biotec and MSKCC are discussing how to move forward
- Exploring other areas where SBG can used as an adjuvant
- In general, experience increased awareness of combination treatments and use of adjuvants
Enzymes
Commercialising the Arctic's Uniqueness
Leveraging uniqueness
Arctic Bioprospecting
• Driven by University of Tromsø (UiT) • Large biobank of novel enzymes
Discovery
- Identifying commercially attractive & novel enzymes • Engineering & formulation to enhance desired features
- Product Development & Manufacturing • Cost efficient manufacturing • Scalability & customisation
Commercialisation
- B2B product offering => Early access
- Support for application development (integration into customer workflows)
Products and segments
Products and Pipeline Segments
Molecular research
Molecular diagnostics
Other markets
Product development
6 product launches in 2016
- HL-Exol
- Glycerol-free dsDNase
- Glycerol-free HL-dsDNase
- IsoPol DNA polymerase
- Glycerol-free COD UNG
- One tubed ASAP
Commercial
ArcticZymes Polymerase (courtesy of A. Larsen, NorStruct, UiT)
- Signed a new 5 year supply agreement with a European based global molecular diagnostic developer in 2016
- Signed in total 3 supply agreements global molecular diagnostic market
- IsoPol Polymerase gaining interst and several evaluations conducted in 2016 and into 2017
- Polymerase's as a "portfolio of diverse enzymes" represents the largest potential for ArcticZymes.
Outlook 2017
Outlook 2017
- Drive commercial traction in core markets for Woulgan®
- Retain position in the Animal Health market with a modest growth
- Build commercial platform in Consumer Health
- Explore commercial opportunities for use of SBG as an adjuvant
- Launch further products in ArcticZymes including Polymerases
- Continue to widen ArcticZymes' commercial platform with new agreements, customers and markets
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