Conference on Q2 FY2023
(April 1 to September 30, 2023)
Financial Results
Hiroshi Nomura, President and CEO Sumitomo Pharma Co., Ltd.
October 31, 2023
Disclaimer Regarding Forward-looking Statements
This material contains forecasts, projections, goals, plans, and other forward-looking statements regarding the Group's financial results and other data. Such forward-looking statements are based on the Company's assumptions, estimates, outlook, and other judgments made in light of information available at the time of disclosure of such statements and involve both known and unknown risks and uncertainties.
Accordingly, forecasts, plans, goals, and other statements may not be realized as described, and actual financial results, success/failure or progress of development, and other projections may differ materially from those presented herein.
Information concerning pharmaceuticals and medical devices (including those under development) contained herein is not intended as advertising or as medical advice.
© Sumitomo Pharma Co., Ltd. All Rights Reserved. | 1 |
Financial Results for Q2 FY2023
© Sumitomo Pharma Co., Ltd. All Rights Reserved. | 2 |
Financial Results for Q2 FY2023
Financial Results for Q2 FY2023 (Core Basis)
The forecasts are not revised
Billions of yen
Q2YTD | Q2YTD | Change | |||
FY2022 | FY2023 | ||||
Value | FX impact | % | |||
Results | Results | ||||
Revenue | 319.3 | 152.6 | (166.6) | 3.8 | (52.2) |
Cost of sales | 92.8 | 60.3 | (32.5) | (7.6) | (35.0) |
Gross profit | 226.4 | 92.3 | (134.1) | 11.4 | (59.2) |
SG&A expenses | 152.3 | 118.8 | (33.5) | 4.2 | (22.0) |
R&D expenses | 49.4 | 45.3 | (4.1) | 1.5 | (8.3) |
Other operating income/expenses | 0.0 | 5.9 | 5.9 | - | - |
Core operating profit | 24.8 | (65.8) | (90.7) | 5.7 | - |
Non-recurring items | (53.8) | (20.6) | 33.1 | ||
(negative number indicates net loss) | |||||
Operating profit | (28.9) | (86.5) | (57.6) | - | |
Finance income/costs | 49.9 | 30.4 | (19.6) | ||
Profit before taxes | 21.0 | (56.1) | (77.2) | - | |
Income tax expenses | 36.3 | 11.6 | (24.7) | ||
Net profit | (15.2) | (67.7) | (52.5) | - | |
Net profit attributable to owners | (7.3) | (67.7) | (60.5) | - | |
of the parent | |||||
Average rates: | Period end rates: |
FY2023
May 15 | % |
forecasts | |
362.0 42.2
- 45.7
- 40.1
- 54.0
- 53.9
12.0 48.9
(62.0) 106.2
(16.0)
(78.0) | 110.9 |
(3.0) | |
(81.0) | |
(1.0) | |
(80.0) | 84.7 |
(80.0) | 84.7 |
- Revenue decreased significantly due
to LATUDA®'s loss of exclusivity in the U.S. - Share transfer of Sumitomo Pharma Animal Health Co., Ltd. included in Other operating income/ expenses
- Business structure improvement expenses in North America recognized as Non- recurring items
Q2 FY2022 Results : 1US$ = ¥134.05, 1RMB = ¥19.89 | As of the end of March 2023 |
Q2 FY2023 Results : 1US$ = ¥141.07, 1RMB = ¥19.75 | As of the end of September 2023 |
FY2023 forecasts : 1US$ = ¥130.00, 1RMB = ¥19.50 |
- 1US$ = ¥133.54, 1RMB = ¥19.42
- 1US$ = ¥149.58, 1RMB = ¥20.50
© Sumitomo Pharma Co., Ltd. All Rights Reserved. | 3 |
Financial Results for Q2 FY2023
Financial Results for Q2 FY2023 (Core Basis) - vs. Q2 YTD FY2023 Plans
Billions of yen
Q2YTD | Q2YTD | Change | ||||
FY2023 | FY2023 | |||||
Value | % | FX impact | % | |||
Plans | Results | (w/o FX) | ||||
Revenue | 166.2 | 152.6 | (13.6) | 91.8 | 6.3 | 88.0 |
Cost of sales | 60.6 | 60.3 | (0.2) | 99.6 | 2.2 | 96.0 |
Gross profit | 105.7 | 92.3 | (13.3) | 87.4 | 4.1 | 83.5 |
SG&A expenses | 116.1 | 118.8 | 2.6 | 102.3 | 6.8 | 96.4 |
R&D expenses | 44.3 | 45.3 | 1.0 | 102.3 | 2.3 | 97.0 |
Other operating income/expenses | 7.0 | 5.9 | (1.1) | 84.4 | - | 84.4 |
Core operating profit | (47.8) | (65.8) | (18.1) | - | (5.0) | - |
Average rates:
Q2 FY2023 Results : 1US$ = ¥141.07, 1RMB = ¥19.75
FY2023 forecasts : 1US$ = ¥130.00, 1RMB = ¥19.50
© Sumitomo Pharma Co., Ltd. All Rights Reserved. | 4 |
Financial Results for Q2 FY2023
Revenue of Major Products in North America
Q2YTD | Q2YTD | Q2YTD | Q2YTD | Change | FY2023 | |||||||||
FY2022 | FY2023 | Change | FY2022 | FY2023 | ||||||||||
FX | Yen-basis | |||||||||||||
Results | Results | Results | Results | Value | % | May 15 forecasts | ||||||||
% | ||||||||||||||
impact | ||||||||||||||
North America | Billions | |||||||||||||
Million $ | Billions of yen | Million $ | ||||||||||||
of yen | ||||||||||||||
ORGOVYX® | 79 | 138 | 58 | 10.6 | 19.4 | 8.8 | 1.0 | 82.4 | 396 | 51.5 | 37.7 | |||
MYFEMBREE® | 10 | 29 | 19 | 1.4 | 4.2 | 2.8 | 0.2 | 198.5 | 192 | 24.9 | 16.7 | |||
GEMTESA® | 71 | 112 | 42 | 9.5 | 15.8 | 6.4 | 0.8 | 67.2 | 362 | 47.0 | 33.6 | |||
APTIOM® | 129 | 114 | (15) | 17.4 | 16.1 | (1.2) | 0.8 | (7.0) | 273 | 35.5 | 45.5 | |||
RETHYMIC® | 19 | 22 | 3 | 2.6 | 3.1 | 0.5 | 0.2 | 20.3 | 54 | 7.0 | 44.0 | |||
LATUDA® | 952 | 29 | (923) | 127.6 | 4.0 | (123.6) | 0.2 | (96.8) | 161 | 20.9 | 19.3 | |||
Others | 60 | 9 | (51) | 8.0 | 1.2 | (6.8) | 0.1 | (84.9) | 167 | 22.0 | 48.4 | |||
Export products/ | 137 | 67 | (70) | 18.3 | 9.4 | (8.9) | 0.5 | (48.4) | ||||||
Lump-sum revenue, etc.* | ||||||||||||||
Total | 1,457 | 519 | (938) | 195.3 | 73.3 | (122.1) | 3.6 | (62.5) | 1,605 | 208.8 | 35.1 | |||
* Major items included in Export products/Lump-sum revenue, etc. | ||||||||||||||
Q2YTD | Deferred revenue from the collaboration with Pfizer of $80M | Q2YTD | ||||||||||||
Deferred revenue from the collaboration with Pfizer of $59M | ||||||||||||||
FY2022 Revenue from the license agreement for ORGOVYX® in EU of $50M | FY2023 | |||||||||||||
(Ref.) Achievement rate against Q2 YTD plans for three key products
Million $ | ||
Plans | Results | % |
155 | 138 | 88.7 |
60 | 29 | 49.3 |
156 | 112 | 72.0 |
- Of the "Export products/Lump- sum revenue, etc." in Q2 FY2022, the lump-sum revenue under the license agreement for ORGOVYX® in EU was $50M. (See the breakdown below the table)
Average rates:
Q2 FY2022 Results : 1US$ = ¥134.05
Q2 FY2023 Results : 1US$ = ¥141.07
FY2023 forecasts : 1US$ = ¥130.00
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 5
Financial Results for Q2 FY2023
Marketing Status of ORGOVYX®
Plan for Q2 | Actual for Q2 | Achievement rate against | Volume and price of influence against | |
YTD FY2023 | YTD FY2023 | plan for Q2 YTD FY2023 | actual for Q2 YTD FY2023, $138M | |
$155M | $138M | 89% | Volume | Unfavorable. approx. ($23M) |
Price | Favorable. approx. $6M | |||
- ORGOVYX® continues to show strong growth - H1 FY2023 revenue increased approx. 75% compared to H1 FY2022 and provides important treatment advantages, as the first oral GnRH antagonist in the U.S., for advanced prostate cancer
- Forecasted volume was not achieved due to slower than anticipated market share while price was favorable vs. forecast due to lower prior quarter adjustments tied to coverage gap liability in Medicare Part D
FY2023 Strategies and Outlook | |
Urology in-office-dispensing clinics (approx. 19% of ADT Market*1): Utilizing analysis of Advanced Analytics team*2 to | |
inform appropriate promotional messaging and improve timing of sales reps visit a prescribing physician in June | |
Volume | Academic/Integrated Delivery Network (approx. 50% of ADT Market): Introduced Strategic Account Manager team in |
July focused on supporting adoption of ORGOVYX® in hospital setting | |
Changes in Medicare Part D benefit design will improve ORGOVYX® affordability for patients as of Jan. 2024 by | |
eliminating out of pocket following catastrophic phase and increasing the low income subsidy threshold | |
Price | Gross to net expected to be consistent with current trends |
*1 | Androgen Deprivation Therapy market where ORGOVYX® is prescribed | © Sumitomo Pharma Co., Ltd. All Rights Reserved. | 6 |
*2 | SMPA's Advanced Analytics Computational Technology & Research (AACTR), which leverages SMPA's digital infrastructure, including DrugOME and Digital Innovation |
Financial Results for Q2 FY2023
Marketing Status of MYFEMBREE®
Plan for Q2 | Actual for Q2 | Achievement rate against | Volume and price of influence against | |
YTD FY2023 | YTD FY2023 | plan for Q2 YTD FY2023 | actual for Q2 YTD FY2023, $29M | |
$60M | $29M | 49% | Volume | Unfavorable. approx. ($24M) |
Price | Unfavorable. approx. ($7M) | |||
- MYFEMBREE® continues to grow - H1 FY2023 revenue has increased approx. 190% increase compared to H1 FY2022.
- TRx and NBRx share* in uterine fibroids (UF) and endometriosis (EM) of GnRH antagonists market are 37% and 46% in Sep. 2023 (30% and 40% in March 2023)
- Volume of forecast was not achieved due to slower than anticipated market share especially in endometriosis and price of forecast was not achieved due to higher proportion of Medicaid volume and Co-pay cards assistance
FY2023 Strategies and Outlook
- Position MYFEMBREE® as the standard of care for women with UF or EM:
- UF: Establish MYFEMBREE® as GnRH therapy use earlier in the treatment journey by positioning GnRH antagonists as treatment of choice after first oral contraceptive failure
Volume | EM: Establish MYFEMBREE® as GnRH of choice by differentiating MYFEMBREE® on effectively treating pain |
- Continuous field force targeting optimization in collaboration with the Advanced Analytics team and Pfizer Inc.
- Leveraging Advanced Analytics team to improve DTC effectiveness/efficiency and partnering with Pfizer Inc. to launch new DTC
Price Monitoring usage and reinforcing proper use of Co-pay cards
© Sumitomo Pharma Co., Ltd. All Rights Reserved. | 7 |
*Source: Symphony METYS - Data through September 2023, IDV® |
Financial Results for Q2 FY2023
Marketing Status of GEMTESA®
Plan for Q2 | Actual for Q2 | Achievement rate against | Volume and price of influence against | |
YTD FY2023 | YTD FY2023 | plan for Q2 YTD FY2023 | actual for Q2 YTD FY2023, $112M | |
$156M | $112M | 72% | Volume | Unfavorable. approx. ($14M) |
Price | Unfavorable. approx. ($30M) | |||
- GEMTESA® continues to grow - H1 FY2023 revenue has increased approx. 58% increase compared to H1 FY2022
- TRx and NBRx Share* in Beta3 are 21% and 32% in Sep. 2023 (16% and 28% in March 2023)
- Volume of forecast was not achieved due to lower than assumed Beta3 market share and price of forecast was not achieved due to higher proportion of Medicare Part D volume and lower proportion of non-contracted volume
FY2023 Strategies and Outlook | |
Focus on increasing awareness (currently approx. 30%) and prescription uptake in primary care and long-term care, | |
Volume | which account for approx. 45% of total prescriptions for over active bladder |
Plan to conduct a satellite media tour during Bladder Health Awareness Month in Nov. to raise awareness, in | |
addition to the digital advertising currently being conducted on the web and in clinic waiting rooms | |
Price | Price is expected to be improved in Q4 FY2023 because pharmaceutical companies' burden of the Coverage Gap |
in Medicare Part D will be lower in Q4 FY2023 than in other quarters | |
* Source IQVIA NPA
© Sumitomo Pharma Co., Ltd. All Rights Reserved. | 8 |
Financial Results for Q2 FY2023
Revenue of Major Products in Japan & Asia
Billions of yen
Q2YTD | Q2YTD | Change | FY2023 | ||||
FY2022 | FY2023 | ||||||
Value | % | May 15 | % | ||||
Results | Results | forecasts | |||||
Japan | |||||||
Equa®/EquMet® | 17.3 | 15.8 | (1.5) | (8.7) | 32.4 | 48.7 | |
TRERIEF® | 8.6 | 8.5 | (0.0) | (0.5) | 15.0 | 57.0 | |
LATUDA® | 4.6 | 5.7 | 1.1 | 23.3 | 12.5 | 45.8 | |
METGLUCO® | 4.0 | 3.7 | (0.2) | (5.8) | 7.5 | 49.6 | |
TWYMEEG® | 0.5 | 2.6 | 2.1 | 420.7 | 4.2 | 62.9 | |
LONASEN® Tape | 1.4 | 1.8 | 0.4 | 31.7 | 3.3 | 55.5 | |
AG products | 4.6 | 4.6 | (0.0) | (0.7) | 8.6 | 53.5 | |
Trulicity® * | 16.7 | - | (16.7) | - | - | - | |
Others | 8.7 | 10.9 | 2.1 | 24.5 | |||
Export products/ | 9.6 | 3.5 | (6.1) | (63.6) | 30.6 | 51.3 | |
Lump-sum revenue, etc. | |||||||
Non-pharmaceutical operations | 22.1 | 1.3 | (20.8) | (94.1) | |||
Total | 98.1 | 58.5 | (39.5) | (40.3) | 114.1 | 51.3 | |
Asia | |||||||
MEROPEN® (China) | 18.7 | 10.2 | (8.5) | (45.3) | 18.7 | 54.8 | |
Others | 7.1 | 10.6 | 3.4 | 48.4 | 20.4 | 51.8 | |
Total | 25.9 | 20.8 | (5.0) | (19.5) | 39.1 | 53.2 |
Japan
- Progress is fundamentally on track in total
- Sales of TWYMEEG®, LATUDA®, and LONASEN® Tape continue to grow
- Of the "Export products/Lump- sum revenue, etc." in Q2 FY2022, the lump- sum revenue under the license agreement for DSP-0187 was ¥6.1B
- NHI drug price revision effect (¥2.0B) in total
Asia
- MEROPEN® (China) revenue decreased due to Volume-Based Procurement application
Note: Sales of each product are shown by invoice price (* Trulicity® is shown by NHI drug price) | © Sumitomo Pharma Co., Ltd. All Rights Reserved. 9 |
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Sumitomo Pharma Co. Ltd. published this content on 31 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 October 2023 05:20:13 UTC.