Idorsia - building momentum in 2023 - US Europe
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Europe
US
Japan
Idorsia – building
momentum in 2023
J.P. Morgan Healthcare Conference – 9 Jan 2023
The following information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. 2 J.P. Morgan Healthcare Conference | 9 Jan 2023
“Our achievements in
2022 provide the
foundation for our
success in 2023.”
Jean-Paul Clozel
Chief Executive Officer
3 J.P. Morgan Healthcare Conference | 9 Jan 2023
2022 was a transformative year for Idorsia
2022
Idorsia became a commercial company… …plus a key year for future growth
1Q 1Q 2Q 2Q 2Q 2Q 4Q 4Q 4Q 4Q
Aprocitentan
Cenerimod FILING
QUVIVIQ NDA filed with
Aprocitentan Daridorexant First commercial INITIATION
RESULTS Phase 3 US FDA
QUVIVIQ QUVIVIQ RESULTS LAUNCHES in EU
PIVLAZ APPROVAL Phase 3 Phase 3 Japan
Commercial Commercial
PIVLAZ LAUNCH in US in EU “PRECISION”
LAUNCH in
QUVIVIQ APPROVED in
JAPAN
APPROVED in JAPAN
US
4 J.P. Morgan Healthcare Conference | 9 Jan 2023
QUVIVIQ™ (daridorexant) Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant is approved throughout the European Union and in Switzerland and is currently under review in Canada. 5 J.P. Morgan Healthcare Conference | 9 Jan 2023
QUVIVIQ has the highest level of satisfaction
Level of Satisfaction with Insomnia Treatments
C
Trazodone 2% 73% 25%
Belsomra 3% 66% 31%
Z drugs 5% 65% 30%
Dayvigo 2% 62% 36%
A
QUVIVIQ 2% 54% 44%
DETRACTORS PASSIVES PROMOTERS
(0-6 on 10 pt. scale) (7-8 on 10 pt. scale) (9-10 on 10 pt. scale)
Source: Q3 2022 HCP ATU
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
6 J.P. Morgan Healthcare Conference | 9 Jan 2023
QUVIVIQ has the highest level of satisfaction with
access being the strongest barriers to prescribing
Level of Satisfaction with Insomnia Treatments Barriers to Prescribing Treatments
QUVIVIQ
Trazodone 2% 73% 25% Step edits required by insurance 67%
Belsomra 3% 66% 31% Out-of-pocket cost for patients 66%
Time to get insurance approval 65%
Z drugs 5% 65% 30%
Time to complete necessary
59%
Dayvigo 2% 62% 36% paperwork/staff time
Formulary restrictions at my
38%
A practice
QUVIVIQ 2% 54% 44%
Lack of appropriate patients 20%
DETRACTORS PASSIVES PROMOTERS
(0-6 on 10 pt. scale) (7-8 on 10 pt. scale) (9-10 on 10 pt. scale)
Risk of side-effects/safety concerns 14%
Source: Q3 2022 HCP ATU
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
7 J.P. Morgan Healthcare Conference | 9 Jan 2023
HCP awareness of QUVIVIQ
continues to grow
QUVIVIQ Belsomra Dayvigo
94%
68% 70%
62%
38%
25%
UnAided Awareness Aided Awareness
Source: HCP ATU – October 2022 Pulse
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
8 J.P. Morgan Healthcare Conference | 9 Jan 2023Strong & growing demand…
QUVIVIQ Monthly TRxs by Strength QUVIVIQ Monthly TRxs by Source
16'000
25mg 50mg Total QUVIVIQ VitaCare IQVIA
14'000
12'000
10'000
72%
8'000
70%
71%
6'000
72%
4'000
73%
2'000 73% 28%
29% 30%
78% 28%
27% 27%
0 22%
May Jun Jul Aug Sep Oct Nov May Jun Jul Aug Sep Oct Nov
Source: IQVIA + VitaCare Pharmacy Services
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
9 J.P. Morgan Healthcare Conference | 9 Jan 2023…along with sustained growth in
our writer base
Cumulative QUVIVIQ Writers % Writers by Specialty
13'600
14%
11'083
8'509
22%
64%
5'833
3'789
2'361
908 Primary Care Physicians
Psychiatrist
May Jun Jul Aug Sep Oct Nov
Other
Source: IQVIA + VitaCare dispenses through 2022-11-30
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
10 J.P. Morgan Healthcare Conference | 9 Jan 2023Quickly becoming the leading branded
insomnia medicine in NBRx – with accelerating CBRx
New to brand prescriptions (NBRx) Continued brand prescriptions (CBRx)
2'500 2'500
2'000 2'000
Belsomra
1'500 1'500
QUVIVIQ
1'000 1'000
500 500
Dayvigo
0 -
6-May 6-Jun 6-Jul 6-Aug 6-Sep 6-Oct 6-Nov 6-Dec 6-May 6-Jun 6-Jul 6-Aug 6-Sep 6-Oct 6-Nov 6-Dec
Source: IQVIA + Vitacare Fills data
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
11 J.P. Morgan Healthcare Conference | 9 Jan 2023On track to become a global brand
New Drug Submission
under review with
Health Canada
Approved by the European
Medicines Agency and MHRA
Launched in the US
Launched in Germany and Phase 3 study
Italy with further EU successful in Japan;
countries to follow filing expected in
H2 2023
Approved by Swissmedic
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
12 J.P. Morgan Healthcare Conference | 9 Jan 2023QUVIVIQ off to a great start in Germany
Volume of packs purchased by pharmacies
700
25mg 50mg
600
500
61%
60%
400
72%
62%
300
57%
200
60% 40% 39%
100 38%
43% 28%
40%
0
W 46 W 47 W 48 W 49 W 50 W 51 Source: IQVIA
Daridorexant is available in the US and the first countries in Europe under the tradename QUVIVIQ. In addition, daridorexant
is approved throughout the European Union and in Switzerland and is currently under review in Canada.
13 J.P. Morgan Healthcare Conference | 9 Jan 2023PIVLAZ™ (clazosentan) Clazosentan is only marketed in Japan under the tradename PIVLAZ™. In other countries, clazosentan is investigational, in development and not approved or marketed. 14 J.P. Morgan Healthcare Conference | 9 Jan 2023
Successful launch in Japan
Approved in January 2022, launched in April 2022
Expert engagement to
improve treatment of
aSAH patients
>95% ~25%
of target accounts of aSAH patients
are ordering treated with
PIVLAZ PIVLAZ in
November 2022
Clazosentan is only marketed in Japan under the tradename PIVLAZ™. In other countries, clazosentan
is investigational, in development and not approved or marketed.
15 J.P. Morgan Healthcare Conference | 9 Jan 2023Our drug discovery engine continues to deliver
Compound Mechanism of action Target indication Status
QUVIVIQ™ Commercially available as QUVIVIQ in the US and the first countries in Europe.
Dual orexin receptor antagonist Insomnia Approved in Switzerland. Under review in Canada. Phase 3 in Japan successful
(daridorexant) – filing expected in H2 2023. Phase 2 in pediatric insomnia – recruiting.
PIVLAZ™ Cerebral vasospasm associated with Commercially available as PIVLAZ in Japan.
Endothelin receptor antagonist Global Phase 3 – complete.
(clazosentan) aneurysmal subarachnoid hemorrhage
Aprocitentan* Dual endothelin receptor antagonist Difficult-to-control hypertension NDA submitted, MAA in preparation
Phase 3 primary endpoint not met,
Lucerastat Glucosylceramide synthase inhibitor Fabry disease Open Label Extension study ongoing
Selatogrel P2Y12 inhibitor Suspected acute myocardial infarction Phase 3 recruiting
Cenerimod S1P1 receptor modulator Systemic lupus erythematosus Phase 3 recruiting
ACT-1004-1239 ACKR3 / CXCR7 antagonist Multiple sclerosis Phase 2 in preparation
Sinbaglustat GBA2/GCS inhibitor Rare lysosomal storage disorders Phase 1 complete
ACT-1014-6470 C5aR1 antagonist Immune-mediated disorders Phase 1
ACT-777991 CXCR3 antagonist Recent-onset Type 1 diabetes Phase 1
IDOR-1117-2520 Undisclosed Immune-mediated disorders Phase 1
* In collaboration with Janssen Biotech to jointly develop aprocitentan, Janssen Biotech has sole commercialization rights worldwide.
Neurocrine Biosciences has a global license to develop and commercialize ACT-709478 (NBI-827104), Idorsia's novel T-type calcium channel blocker.
ACT-709478 was investigated in a Phase 2 study for the treatment of a rare form of pediatric epilepsy. The study did not meet the primary endpoint.
ACT-709478 was generally well tolerated. Neurocrine continues to analyze the data generated in the study to determine next steps.
16 J.P. Morgan Healthcare Conference | 9 Jan 2023Aprocitentan has significant and sustained efficacy
Part 3
Part 1 Part 2 Double blind
Double blind Single blind withdrawal
Placebo
Aprocitentan 12.5 mg
Aprocitentan 25 mg
*Primary endpoint
P=0.0042 for aprocitentan 12.5 mg vs placebo
P=0.0046 for aprocitentan 25 mg vs placebo
†Key secondary endpoint
PEfficacy confirmed by Ambulatory BP monitoring
at Week 4 (DB Part 1) Daytime Night-time
*
** †
**
*P=0.003, †P=0.0002, **PAprocitentan for difficult-to- control hypertension New mode of action in systemic hypertension Aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated • New drug application (NDA) filed with the US FDA Dec 2022 • Applications to other health authorities anticipated in 2023 • Janssen to commercialize – Idorsia entitled to tiered royalties Aprocitentan is investigational, in development and not approved or marketed in any country. 19 J.P. Morgan Healthcare Conference | 9 Jan 2023
Selatogrel – Potential to change the way
AMI is treated
‘Fast’ onset ‘Short’ duration
of action of action
Potent and highly Suitable for
selective P2Y12 subcutaneous
inhibitor injection
Selatogrel is investigational, in development and not approved or marketed in any country.
20 J.P. Morgan Healthcare Conference | 9 Jan 2023Treatment approach in Phase 3 SOS-AMI
Onset of AMI Self-administer Patient calls for First medical Emergency medical
symptoms selatogrel using emergency service or contact care follow-up at
autoinjector at travels to hospital hospital
symptom onset
Slowing or stopping Our
Heart hope:
attack Early intervention leads to
in progress
of the heart attack better short-term and long-term outcome
Selatogrel is investigational, in development and not approved or marketed in any country.
21 J.P. Morgan Healthcare Conference | 9 Jan 2023CARE Phase 2b delivered according to promise
• Clinically meaningful improvement in disease
4 mg cenerimod activity
selected for Phase 3 − Treatment effect increases over time
Potential to be the − Treatment effect is increased in patients with
greater disease severity and high IFN-1 gene
first new generation signature at baseline
oral drug for SLE
• Favorable safety profile
− Low rate of serious AEs and infections
Cenerimod is investigational, in development and not approved or marketed in any country.
22 J.P. Morgan Healthcare Conference | 9 Jan 2023OPUS: Confirmatory program design
Two Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group
studies to evaluate the efficacy, safety, and tolerability of cenerimod in adult patients
with moderate-to-severe SLE on top of background therapy
Open-label extension
Randomization
2 groups (1:1) End-of- Final study
treatment visit
Background Cenerimod 4 mg (210 patients)
Oral cortico
steroids
reduction Placebo (210 patients)
Visit 1 Visit 2 Visit 8 Visit 14 Visit 20
Day-60 Day 1 Month 6 Month 12 Month 18
Screening Treatment Period Follow up
Up to 60 12 months 6 months
days
Cenerimod is investigational, in development and not approved or marketed in any country.
23 J.P. Morgan Healthcare Conference | 9 Jan 2023Profitability
target
The company is committed to reach
sustainable profitability in 2025 with
global revenue above CHF 1 billion
Based on:
• Sales of QUVIVIQ
• Sales of PIVLAZ in Japan
• Tiered royalties on aprocitentan
Excluding unforeseen events
24 J.P. Morgan Healthcare Conference | 9 Jan 2023Momentum building catalysts in 2023
2023
1H 1H 1H 1H 1H mid- 2H 2H end-
Aprocitentan
QUVIVIQ FDA decision
QUVIVIQ NDA in US
Lucerastat QUVIVIQ
QUVIVIQ Launch
Launch submission
Aprocitentan Future path
Regulatory in UK in Japan
Clazosentan MAA decision in Switzerland
QUVIVIQ decision
Deliver results submission
Secure broader in Canada
Phase 3 “REACT” in Europe
payer coverage
in US †
†EffectiveJanuary 15, 2023, QUVIVIQ will be covered at parity to the other branded dual orexin receptor antagonist
products for the Express Scripts National Preferred Formulary.
25 J.P. Morgan Healthcare Conference | 9 Jan 2023You can also read
