interim results presentation six months ended 31 … · • alkindi® marketing authorisation...
TRANSCRIPT
Diurnal Group plc Interim Results Presentation
Six months ended 31 December 2017
On track to becoming a world leading endocrinology specialty pharma company
12 March 2018Date of preparation March 2018 Ref: CORP-GB-00091
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No statement in this presentation is intended as a profit forecast or profit estimate.
Past performance is no guide to future performance and persons needing advice should consult an independent financial adviser.
2
Investment summary
On track to become a world-leading endocrinology specialty pharma company focused on ca. $10bn market opportunity
• Initially targeting >$3bn market in cortisol deficiency
• First product, Alkindi®, recently received marketing authorisation approval in Europe
• Sales and marketing infrastructure in place for commercial launches in Europe
• Second product, Chronocort®, due to complete European PIII trial in Q3 2018
– Marketing authorisation approval in Europe anticipated in 2020
• Seeking commercial partners in US and RoW to enter global markets
• Commercial exclusivity until 2034 – orphan drug, regulatory and patents1
• Earlier stage product pipeline entering clinical trials
31. Conditional and subject to grant of market authorisation (and that the Company is the first sponsor to obtain market authorisation for the relevant product), on grant of
pending patents and ongoing grant
The vision
To become a world leading endocrinology specialty pharma company
• Establish commercial traction via lead product candidates• Continue to develop specialist products and bring them to market• Potential for targeted M&A to accelerate and leverage international profile
4
5
Half year highlights
Operational highlights (During the period and post period end)
Alkindi® – first country launch planned for Q2 2018
Europe
• Grant of a PUMA by the EC for Alkindi® as replacement therapy of paediatric AI
– Followed CHMP positive opinion in December 2017
US
• Alkindi® IND application successfully opened with the US FDA
– Food matrix compatibility study met primary endpoint with high statistical significance
Chronocort® – Phase III trial data expected in H2 2018
Europe
• Completion of patient recruitment for the European Phase III trial of Chronocort® in CAH
US
• Appointment of global CRO for Chronocort® US development programme to commence during 2018
– Followed written feedback received from FDA Phase III pivotal trial design
6
Alkindi® and Chronocort® – maximising potential outside core markets
US
• Grant of first US patent for Chronocort®
Japan
• Grant of first Japanese patents for Alkindi® and Chronocort®
RoW
• Marketing and distribution agreement with Emerge Health for Alkindi® and Chronocort® in Australia and New Zealand
Creating a strong European commercialisation capability
• Continued development of European commercial organisation and supply chain
– Includes establishment of wholly-owned subsidiary Diurnal Europe B.V. in The Netherlands to mitigate Brexit risk
7
Operational highlights (During the period and post period end)
8
The opportunity
Note: diagram shows the Company’s view of dominant areas of focus within the endocrinology market
Large pharma Large specialty pharma Small niche endocrinology
Eli Lilly
SanofiNovo Nordisk Pfizer
NovartisAbbott Ipsen FerringEndo Corcept
Strongbridge
Chiasma
HRA Pharma
Diurnal is seeking to build a commercial franchise in niche areas of unmet patient need
9Source: Company estimates based on publicly available information.
Endocrine focussed development pipeline
10
Annual Addressable
Market (Europe & US)
Estimated
Approval
$1,000mTBC
$480mTBC
$5,157mTBC
TBC
Indication
Cushing’s DiseaseOligo-nucleotide
T3 modified release
Testosterone
$410m2020
2021
$2,770mTBC
Congenital Adrenal Hyperplasia (CAH) (Adult)
Chronocort®
$82mApproved
2020Alkindi®
CAH & AI (Under 18 years)
CAH & AI (Under 16 years)
Classical Hypogonadism
Hypothyroidism (T4 non-responders)
Rheumacort® Inflammatory diseases TBC TBC
Adrenal Insufficiency (AI) (Adult)
In Progress/Completed Line extension based on Phase I dataKey:
Source: Company market estimates based on Datamonitor Report (2015), pricing from British National Formulary and GBP:USD exchange rate as of 2 January 2018
MAAPIIPIPre- PIII
Diurnal aims to have two licensed products in a ca. $0.5bn market with ca. 10 years’ exclusivity by 2021
Alkindi® Chronocort®
0 18 YEARS
Life-long
Licensed & measured dosing1Matching circadian rhythm
Building a life-long “Adrenal Franchise”
111. Reflects the position in Europe
Cortisol – an essential hormoneCortisol deficiency results in fatigue, depression and death through adrenal crisis
Target indications Key products
Adrenal Insufficiency (AI): Patients lose the ability to produce cortisol leading to insufficient cortisol production
Alkindi®: Approved by the EMA as the first licensed hydrocortisone product specifically designed to treat children <18 years in Europe
Congenital Adrenal Hyperplasia (CAH): Patients are born without an enzyme that stimulates the adrenal glands to release the hormone cortisol
Chronocort®: Aims to be the first hydrocortisone product that closely mimics cortisol circadian rhythm
$82m market $410m market
Significant value inflection points expected in 2018
12
• Alkindi® launch in key European territories; generation of first revenue expected in Q2 2018
• Chronocort® European Phase III clinical trial (CAH) to complete in Q3 2018
• Alkindi® US Phase III clinical programme (paediatric AI, including CAH) anticipated to complete in 20181
• Chronocort® US Phase III clinical study (CAH) to commence mid-20181
Approved(Feb-18)
Estimated ApprovalPhase III1
Estimated Approval
Estimated Approval
Phase III
Phase III1
Alkindi®
(AI & CAH)
Chronocort®
(CAH)
Alkindi®
(AI & CAH)
Chronocort®
(CAH)
$60m
$300m
$22m
$110m
Chronocort®
(AI)$2,770m Phase II
Addressable market
Next steps2018 2019 2020 2021
Source: Company estimates, market estimates based on Datamonitor Report (2015), pricing from British National Formulary (No. 74) and GBP:USD rate as of 2 January 20181. Subject to confirmation from the FDA
Competitive landscape; differentiated products
13
ProductMimics
circadian rhythm
IndicationCountries PriceAI/CAH
paediatric1CAH AI
Hydrocortisone(generic)
Unlicensed
ca. $3.3k p.a.
Plenadren®(modified release) ca. $6.3k p.a.
Diurnal“Adrenal Franchise”
Chronocort®
Alkindi®
Chronocort®
Chronocort®
Targeting $6.3k+ p.a.
• Generic hydrocortisone provides no circadian release & only achieves poor disease control
• Plenadren® is modified release hydrocortisone, does not provide overnight coverage of cortisol and has not demonstrated disease control
• Chronocort® has the only CAH Orphan Drug Designation in Europe
• In the US, there are a handful of competitor products vying for exclusive marketing rights in CAH:
1. Under 6 years in Europe and under 16 years in US; Source: British National Formulary (No. 74); Han et al (2014); EMA Assessment Report for Plenadren® (21 July 2011)
Chronocort®Diurnal
ATR-101 Millendo Therapeutics
SPR001 Spruce Biosciences
NBI-74788Neurocrine Biosciences
Phase III scheduled to start mid-2018
Phase II completed Enrolling to Phase II trial Enrolling to Phase I trial
14
Alkindi® (AI & CAH children)
The first product specifically designed for children suffering from AI and CAH
Chronocort® (CAH adults)
Aims to be the first hydrocortisone product that mimics cortisol
circadian rhythm
Pharmacy compounded adult tablets 25% out of specification1
Formulations that are
challenging to administer
Imprecise, inaccurate and highly variable
dosing that risks over- or under-
treatment
Unpalatable, bitter taste
Alkindi®
Chronocort®
Current unlicensed treatments have significant draw backs
2
Alkindi®: A major breakthroughin paediatric AI (including CAH)
151. Out of European Pharmacopeial specification: Neumann et al (2017)2. Proposed Alkindi® market packs subject to confirmation from the EMA
2
Authorised by the EMA as the first licensed hydrocortisone product specifically designed to treat children with AI <18 years in Europe – a $60m market opportunity1
• Alkindi® recommendation for licence approval received from the European Medicines Agency on 15th December 2017
• Alkindi® marketing authorisation approval received from European Commission on 9th
February 2018
• Basis of European approval is the Paediatric Use Marketing Authorisation (PUMA)
– 10 years data and market exclusivity from the date of market authorisation
• Market access plans in place for a timely launch in Europe – Agreements are in place with internationally recognised commercial organisations to ensure a solid commercial
platform for prompt European market access for Alkindi®
• Anticipated launch and first commercial sales in Europe during Q2 2018
Alkindi®
Chronocort®
Alkindi® Europe: On track to launch in Q2 2018
161 Based on Datamonitor Report (2015), pricing from British National Formulary (No. 74) and GBP:USD rate as of 2 January 2018
• Selected Ashfield Healthcare to work with Diurnal to establish a European commercial organisation
– 7 Medical Science Liaison staff (covering Germany, UK, France, Italy and Spain);
– 6 Key Account Managers (covering Germany, UK, Italy and Spain);
– 1 Market Access Manager
– Supplements in-house commercial team
– Rapid and efficient build-out without the need for costly up-front investment in infrastructure
• European commercial organisation is a valuable asset
– Ensures retention of the full value1 of Alkindi®
– An attractive partner for companies seeking to commercialise endocrinology focused products in Europe
• European commercial infrastructure and supply chain will be utilised for Chronocort® roll-out in due course
Alkindi®
Chronocort® European commercialisation strategy
171. Compared to licensing model
Cortisol circadian rhythm
Current hydrocortisone TID
Chronocort® BID “Toothbrush regimen”
0
100
200
300
400
500
600
700
800
Seru
m C
ort
iso
l n
mo
l/l
23:00 03:00 07:00 11:00 15:00 19:00 23:00Time (24 hour clock)
Too little drug
Too muchdrug
Too little drug
10mg HC 5mg HC 2.5mg HC
20mg Chronocort® 10mg Chronocort®
Alkindi®
Chronocort®
Chronocort®: Targeting effective disease control in adults
18Source: Debono et al. JCEM (2009); Mallappa et al JCEM (2014) & company data on file; BID, twice daily; TID, thrice daily
Cortisol – an essential hormone:• Distinct circadian rhythm required for health; CAH can result
in short stature, infertility, obesity, increased mortality
Unsatisfactory current treatment: • 2/3 of CAH patients have poor disease control (androgens)
Chronocort® – innovative drug delivery solution:• Delayed release coat allows pH triggered release in
GI tract
Chronocort® – improved disease control:• Control of morning androgens in 94% of patients vs
31% on standard treatment in Phase II trial
$410m market opportunity
(Europe and US)
Alkindi®
Chronocort®
Chronocort® Europe: Pivotal Phase III trial to complete in Q3 2018
19
# of patients 122 CAH patients dosed
Surrogate end points
Scheduled to completeLast patient, first dose: 11th Feb 2018
Results read-out: 2018
Anticipated market authorisation
2020
Market AccessOrphan Drug Designation secured for both CAH and AI1
IP until 2033 – first patents grantedPotential to command premium pricing
Commercialisation plansMarket directly leveraging existing European sales and
marketing infrastructure
European market opportunity = $300m
Patient recruitment is now complete; expect to complete study in Q3 2018
1. Conditional and subject to grant of market authorisation (and that the Company is the first sponsor to obtain market authorisation for the relevant product), on grant of pending patents and ongoing grant
US registration programme for Alkindi® for the treatment of paediatric adrenal insufficiency – a $22m market opportunity1
• IND for regulatory approval package open with the FDA
– Positive outcome of food matrix compatibility study in healthy adult volunteers
– Recommendation received from FDA for US comparator study design; anticipated to complete in 2018
• Anticipated feedback from FDA around the regulatory package required for market authorisation submission during 2018
Alkindi®
Chronocort®
Alkindi® US: Continued engagement with FDA on Phase III programme
201 Based on Datamonitor Report (2015), pricing from British National Formulary (No. 74) and GBP:USD rate as of 2 January 2018
Alkindi®
Chronocort®
Chronocort® US: Phase III clinical trial to commence in Q3 2018
21
# of patients 150 CAH patients1
Surrogate end points
Scheduled to start 2018
Anticipated market authorisation
2021
Market AccessOrphan Drug Designation secured for both CAH and AI2
Granted patent protection until 2033 Potential to command premium pricing
Commercialisation plansSeek partner for commercialisation in US for optimal market
access
$110m market opportunity
Pivotal study scheduled to start in mid-2018
1. Subject to final study design in line with FDA advice2. Conditional and subject to grant of market authorisation (and that the Company is the first sponsor to obtain market authorisation for the relevant product), on grant of
pending patents and ongoing grant
Alkindi®
Chronocort® Commercialisation strategy: RoW
22
1. Including the Palestinian Authority2. Company estimates based on a price of $6,369 per patient per annum 3. Datamonitor Report (2015) and price of $6,369 per patient per annum
Country PartnerMarketing & Distribution Agreement
First Revenues Patents GrantedAnnual
Addressable Market
Israel1Medison Pharma
Ltd 2019 $6.3m2
Australia & New Zealand
Emerge Health Pty 2020 $10.2m2
Japan TBA TBA TBC $415m3
23
Diurnal’s extended portfolio
Indications
Annual Addressable
Market (Europe & US)
Product
Pituitary Acromegaly $647m1
Thyroid Hypothyroidism $1,000m Modified-release T3
(preclinical)
AdrenalCAH
AICushing’s
$492m$2,770m$480m2
Alkindi® (completed) Chronocort®
(Phase III) Oligonucleotide
therapy (preclinical)
Gonads Hypogonadism $5,157m DITEST (Phase I/II)
Pipeline - a ca. $10bn market opportunity Strategic Opportunities
In-licensing
M&A
Partnerships
Expanding the product portfolio
24
Source: Company estimates based on Datamonitor Report (2015), pricing from British National Formulary and GBP:USD exchange rate as of 2 January 20181. Indicates areas of potential focus beyond the Company’s existing pipeline2. Includes Cushing’s syndrome and disease
25
Half-year financial results
Financial highlights
• Operating loss of £7.7m (H1 2016/17: £5.7m)
– Increased investment in clinical and development activities
– Build out of commercial organisation and pre-commercialisation expenses to support anticipated launch of Alkindi®
• Held-to-maturity financial assets, cash and cash equivalents at 31 December 2017 of £14.0m (31 Dec 2016: £25.6m; 30 Jun 2017: £19.9m)
• Net cash used in operating activities was £5.9m (H1 2016/17: £4.5m)
– In line with the Board’s expectations
• Net assets of £10.8m (31 Dec 2016: £20.6m; 30 Jun 2017: £10.1m)
26
Continuing investment in the pipeline
£000 6 months to31 Dec 2017
6 months to31 Dec 2016
% change
Research and development expenditure (4,713) (3,955) +19%
Administrative expenses (3,000) (1,709) +76%
Operating loss (7,713) (5,664) +36%
Net financial (expense)/income (106) (32) +231%
Taxation 1,149 - n/a
Loss for the period (6,670) (5,696) +17%
Net cash used in operating activities (5,931) (4,519) +31%
Net cash generated by financing activities 19 - n/a
Closing cash and Held-to-maturity financial assets 13,995 25,626 -45%
27
Strong financial position
£000 31 Dec 2017 31 Dec 2016
Non current assets 30 7
Trade and other receivables 4,049 753
Cash & Held-to-maturity financial assets 13,995 25,626
Trade and other payables (3,624) (2,451)
Borrowings (short and long term) (3,657) (3,373)
Net assets 10,793 20,562
Share capital & premium 26,314 26,242
Consolidation reserve (2,943) (2,943)
Other reserve 1,458 1,458
Retained (losses)/earnings (14,036) (4,195)
Total equity 10,793 20,562
28
Investment summary
On track to become a world-leading endocrinology specialty pharma company focused on ca. $10bn market opportunity
• Initially targeting >$3bn market in cortisol deficiency
• First product, Alkindi®, recently received marketing authorisation approval in Europe
• Sales and marketing infrastructure in place for commercial launches in Europe
• Second product, Chronocort®, due to complete European PIII trial in Q3 2018
– Marketing authorisation approval in Europe anticipated in 2020
• Seeking commercial partners in US and RoW to enter global markets
• Commercial exclusivity until 2034 – orphan drug, regulatory and patents1
• Earlier stage product pipeline entering clinical trials
291. Conditional and subject to grant of market authorisation (and that the Company is the first sponsor to obtain market authorisation for the relevant product), on grant of
pending patents and ongoing grant
Strong team with ability to deliver
Opportunities to broaden the offering
Credible market access
strategy
Strong base position in
orphan diseases
Building a global endocrinology
specialty pharma
30
Appendix
31
Martin Whitaker PhD
Chief Executive Officer
Peter Allen
Chairman
• Over 20 years in senior board positions
• Non-Executive Chairman at Clinigen, Advanced Medical Solutions and Oxford Nanopore Technologies and; Non-Executive Director at Istesso
• Previous positions at ProStrakan, Proximagen, Future, Celltech
• 20 years working in pharma and biotech
• Previous positions at Critical Pharmaceuticals, Pfizer
• Founder at D3 Pharma which successfully commercialised Plenachol®, a high dose Vitamin D product
• Over 20 years in senior financial positions
• Previous CFO positions at Mereo Biopharma, Glide Technologies, Verona Pharma and Chroma Therapeutics
• Previous positions at Celltech and AstraZeneca
Richard Ross MD
Chief Scientific Officer
• Over 30 years in senior medical positions
• Diurnal founder, world leading endocrinologist & industry key opinion leader
• Professor of Endocrinology at the University of Sheffield
Experienced leadership team
32
Richard Bungay
Chief Financial Officer
The cortisol deficiency market opportunity
33
Prevalence (Estimated no. of patients) Total Addressable Market Size1
Total Total
Paediatric AI(inc CAH)
9,437 3,504 12,941 $60m $22m $82m
CAH 47,089 17,288 64,377 $300m $110m $410m
AI 296,826 138,242 435,068 $1,890m $880m $2,770m
Total 353,352 159,034 512,386 $2,250m $1,012m $3,262m
Source: Datamonitor Healthcare Consulting, 20151. Based on Plenadren® price point of approximately $6.3k per patient per annum
Robust product protection in key markets
34
Intellectual property
Alkindi®
Chronocort®
Oral Testosterone
DITEST™
USEuropean
Patent
Regulatory exclusivity4
USEU
Orphan 7 years
Orphan 7 years
Orphan 10 years
PUMA
10 years
Not an orphan disease
Not an orphan disease
2034
2032
Composition of matter
Method of treatment (x2)
Under review1
Under review2
Composition of matter
Medical use
2033
2033
Composition of matter
Method of treatment
Composition of matter & medical use
2030Composition of matter
2029Composition of matter
Under review3
2034
1. Granted GB patent number: 2527233;2. Granted GB patent number 2509663; 3. Granted GB patent numbers: GB 2502402 & 2510754;4. Conditional and subject to grant of market authorisation (and that the Company is the first sponsor to obtain market authorisation for the relevant product)
Key investors
351. Includes conversion of IP Group loan of £4.7m into ordinary shares at the IPO price of £1.44 per share, option pool and LTIP (total pool = 4,822,742 shares; management
and Board = 3,245,092 shares)
ShareholderBasic Diluted(1)
Number of shares % holding Number of shares % holding
IP Group 1 23,808,100 45.3% 27,037,675 44.6%
Finance Wales 11,534,888 21.9% 11,534,888 19.0%
Invesco Perpetual 6,527,777 12.4% 6,527,777 10.8%
Oceanwood 4,376,833 8.3% 4,376,833 7.2%
Management and Board 1,790,508 3.4% 5,035,600 8.3%
Others 4,542,528 8.6% 6,120,178 10.1%
Total 52,580,634 100.0% 60,632,951 100.0%
Selected historical financial information1
36
Year ended Year ended13 month
period ended
30 June 2017 30 June 2016 30 June 2015
Income statement (£'000s)
Research and development expenditure (8,340) (3,886) (2,227)
Administrative expenses (3,734) (3,106) (1,000)
Other operating income 9 - 241
Operating loss (12,065) (6,992) (2,986)
Financial income 182 63 8
Financial expense (272) (133) (41)
Loss before tax (12,155) (7,062) (3,019)
Taxation 2,730 491 81
Loss for the period (9,425) (6,571) (2,938)
Cash flow (proforma) (£'000s)
Opening cash and cash equivalents and held to maturity financial assets
30,114 6,073 951
Net cash flow utilised in operating activities (10,450) (5,059) (2,856)
Net cash flows from investing activities2 169 44 3
Net cash generated by financing activities 48 29,056 7,975
Closing Cash and cash equivalents and held to maturity financial assets
19,881 30,114 6,073
1 The Group’s historical financial information has been extracted from its audited consolidated financial statements. 2 The cash flow figures have been adjusted to aggregate the Group’s cash balances and treasury deposits with a maturity of three months or less with treasury deposits that have a maturity of greater than three months.
Chronocort® Phase II (Completed 2014)
37
Description
• 6 month, open label, cross-over study to measure PK and efficacy of Chronocort® in adults with CAH
• Measured a number of secondary outcomes
Patients 16 (adults, male and female)
Location NIH (US)
Outcomes
• Chronocort® twice daily approximates to physiological cortisol rhythm
• Significant improvement in biochemical control of 17-OHP and A4 (surrogates) at 6 months of treatment
• Steroid dose reduction after 6 months of Chronocort® treatment
• No serious adverse events occurred
Control of Androgens
An
dro
gen
s (n
g/d
L)
94% of patients in optimal range
Diurnal – Company history
38
2004Diurnal founded as a spin-out from the University of Sheffield
2005
Diurnal gains EU orphan drug designation for Chronocort® for Congenital Adrenal Hyperplasia (CAH)
2009Institutional shareholder base established and partners engaged to develop Chronocort®
2013Successful completion of Phase I Alkindi® trials in adults, enabling the Company to progress to Phase III paediatric trials
Chronocort® Phase II trial begins in adult CAH patients at the National Institutes of Health (US)
2012Successful conclusion of Chronocort® Phase I trials following development of different formulation, manufacturing process and dosing regimen
2014Positive results from the Chronocort® Phase II trial published in Journal of Clinical Endocrinology and Metabolism
2014-5Diurnal secures further institutional funding to initiate Phase III registration trials of both Alkindi® and Chronocort® in Europe and to further strengthen the management team
2004 - 8Chronocort® intellectual property licensed to Phoqus plc
2007EU orphan drug designation approved for Chronocort® for Adrenal Insufficiency (AI)
2008Chronocort® licence repurchased from administrators of Phoqus plc1
2004 Present
2015Chronocort® gains US orphan drug designationfor both AI & CAH.
Alkindi® gains US orphan drug designation for paediatric AI
Diurnal Group plc lists on AIM as DNL.L
2017Alkindi® receives positive opinion for approval from European Medicines Agency
Alkindi® and Chronocort® patents granted in the US
2016Positive results from Alkindi® Phase III trial announced
First patient dosed in Chronocort® Phase III European trial
First patient dosed in testosterone Phase I/II trial
2018Alkindi® receives market authorisation approval from European Commission
1. Phoqus plc’s version of Chronocort® was different to Diurnal’s new version of Chronocort® due to: i) a different formulation; ii) a different manufacturing process which could not be scaled; iii) a different dosing regimen (once daily); and iv) being in tablet rather than capsule form
Completion of Phase III trial and marketing authorisation of Alkindi® in Europe and of enrolment into European Chronocort® Phase III trial achieved since IPO