Ipsen SA

Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time BRISBANE, Calif., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its third quarter 2024 financial results and highlighted recent corporate achievements. “Our third quarter results demonstrate continued patient demand for OJEMDA, driven by the need for new therapies for children living with pediatric low-grade glioma,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Looking ahead to 2025, we plan to continue to drive growth by advancing our programs and pipeline, including DAY301, a potential first-in-class ADC targeting PTK7 that we expect to be in the clinic in the coming months.” Program Highlights Strong growth in OJEMDA net revenue with $20.1M in the third quarter of 2024, representing a 145% increase over the second quarter of 2024.Quarterly prescriptions (TRx) grew to 619 in the third quarter of 2024, representing a 159% increase over the second quarter of 2024.Day One expects to dose the first patient in the Phase 1a portion of the Phase 1a/b clinical trial of DAY301 by the end of 2024 or in the first quarter of 2025.Day One provided updated duration of response data from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG. For the 77 patients enrolled on Arm 1, which was the dataset used to assess OJEMDA’s efficacy, the median duration of response is 18 months.The pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib as a front-line therapy in patients aged 6 months to 25 years with pLGG continues to enroll patients in the United States, Canada, Europe, Australia and Asia, with more than 100 sites activated. Corporate Highlights and Upcoming Milestones Day One and Ipsen entered into an exclusive licensing agreement to commercialize tovorafenib outside of the U.S. in July 2024. Under the agreement, Day One received approximately $111 million upfront in cash and equity investment at a premium with up to approximately $350 million in additional launch and sales milestone payments as well as tiered double-digit royalties starting at mid-teens percentage on net sales.Day One entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million in July 2024. Third Quarter 2024 Financial Highlights Product Revenue, Net: OJEMDA net product revenues were $20.1 million for the third quarter of 2024, the first full quarter of the U.S. launch.License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $73.7 million for the third quarter of 2024.R&D Expenses: Research and development expenses were $33.6 million for the third quarter of 2024 compared to $33.2 million for the third quarter of 2023. The increase was primarily due to the clinical trial activities related to tovorafenib and additional employee compensation costs.SG&A Expenses: Selling, general and administrative expenses were $29.0 million for the third quarter of 2024 compared to $18.3 million for the third quarter of 2023. The increase was primarily due to employee compensation costs, commercial launch activities, and professional service expenses to support the launch of OJEMDA.Net Income/Loss: Net income totaled $37.0 million for the third quarter of 2024 with non-cash stock-based compensation expense of $11.6 million, compared to a net loss of $46.2 million for the third quarter of 2023, with non-cash stock-based compensation expense of $9.6 million.Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $558.4 million as of September 30, 2024. Upcoming Events Two posters on health-related quality of life and drug holiday from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG will be presented at the Society for Neuro-Oncology Annual Meeting on November 22, 2024.Piper Sandler 36th Annual Healthcare Conference, December 3-5, 2024. Conference Call Day One will host a conference call and webcast today, October 30 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Investors & Media page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event. About OJEMDA™OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases. OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma. For more information, please visit www.ojemda.com. About Day One Biopharmaceuticals Day One Biopharmaceuticals believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One. Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™), DAY301 and a VRK1 inhibitor program. Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X. Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and LinkedIn Home Page (linkedin.com/company/dayonebio) as a means of disseminating or providing notification of, among other things, news or announcements regarding its business or financial performance, investor events, press releases, and earnings releases, and as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Cautionary Note Regarding Forward-Looking StatementsThis press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop and commercialize cancer therapies, expectations from current and planned clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib as designed, expectations with respect to the timing of Day One’s Phase 1a/b clinical trial of DAY301, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain regulatory approvals for tovorafenib and other candidates in development, and the ability of tovorafenib to treat pLGG or related indications. Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law. Day One Biopharmaceuticals, Inc.Condensed Statements of Operations(in thousands, except share and per share amounts)(unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Revenue: Product revenue, net$20,070 $— $28,262 $— License revenue 73,691 — 73,691 — Total revenues 93,761 — 101,953 — Cost and operating expenses: Cost of product revenue 1,590 — 2,297 — Research and development 33,563 33,163 165,879 93,173 Selling, general and administrative 28,972 18,275 85,715 53,374 Total cost and operating expenses 64,125 51,438 253,891 146,547 Income (loss) from operations 29,636 (51,438) (151,938) (146,547)Non-operating income: Gain from sale of priority review voucher — — 108,000 — Investment income, net 5,322 5,291 13,649 12,163 Other income (expense), net 1,197 (3) 1,177 (22)Total non-operating income, net 6,519 5,288 122,826 12,141 Income (loss) before income taxes 36,155 (46,150) (29,112) (134,406)Income tax benefit (expense) 882 — (670) — Net income (loss) 37,037 (46,150) (29,782) (134,406)Net income (loss) per share - basic$0.38 $(0.54) $(0.33) $(1.73)Net income (loss) per share - diluted$0.38 $(0.54) $(0.33) $(1.73)Weighted-average number of common shares used in net income (loss) per share - basic 96,623,123 85,952,501 90,164,895 77,682,237 Weighted-average number of common shares used in net income (loss) per share - diluted 96,937,759 85,952,501 90,164,895 77,682,237 Day One Biopharmaceuticals, Inc.Selected Condensed Balance Sheet Data(in thousands)(unaudited) September 30,2024 December 31,2023Cash, cash equivalents and short-term investments$558,383 $366,347 Total assets 600,807 376,048 Total liabilities 45,344 29,508 Accumulated deficit (488,367) (458,585)Total stockholders’ equity 555,463 346,540 DAY ONE MEDIALaura Cooper, Head of Communications media@dayonebio.com DAY ONE INVESTORSLifeSci Advisors, PJ Kelleherpkelleher@lifesciadvisors.com

Ipsen’s Iqirvo (elafibranor) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat adults with the rare liver disease primary biliary cholangitis (PBC). The drug can now be used in combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA, or as a monotherapy in those who are unable to tolerate UDCA. The recommendation makes Iqirvo the first medicine for PBC to be approved for use on the NHS in nearly a decade and comes just two weeks after the Medicines and Healthcare products Regulatory Agency granted marketing authorisation to the drug in this setting. PBC is characterised by the build-up of bile and toxins (cholestasis) and chronic inflammation, which leads to irreversible scarring of the liver and destruction of the bile ducts. The disease affects approximately 25,000 people in the UK, the majority of whom are women, and is associated with symptoms such as persistent, debilitating itch, known as pruritus, and severe fatigue. The condition can also worsen over time and cause liver failure if not effectively treated. Taken orally once daily, Iqirvo is a peroxisome proliferator-activated receptor agonist that decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. NICE’s decision on the drug was supported by positive results from the phase 3 ELATIVE trial, in which 51% of patients receiving Iqirvo in combination with UDCA achieved a cholestasis response at week 52, compared to 4% of those in the placebo plus UDCA group. Additionally, 15% of Iqirvo-treated patients demonstrated ALP normalisation versus 0% on placebo at week 52, and a greater decrease in pruritus intensity was observed in Iqirvo-treated patients compared to placebo, but this did not reach statistical significance. Iqirvo will be made immediately available via the Innovative Medicines Fund, which facilitates faster access to new treatments while further data is collected. David Montgomery, UK and Ireland medical director at Ipsen, said: “NICE’s decision comes at a pivotal time as currently available treatments do not effectively manage both PBC disease progression and life-impacting symptoms like itch and sleep disturbances. This approval is an important step for us in improving outcomes for people living with PBC…”

PARIS, FRANCE, 23 October 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its performance for the year to date and the third quarter of 2024. YTD 2024 YTD 2023 % change Q3 2024 Q3 2023 % change €m €m Actual CER1 €m €m Actual CER1 Oncology 1 829,8 1 744,1 4,9% 5,8% 604,0 574,5 5,1% 5,6% Neuroscience 536,4 489,0 9,7% 11,8% 181,9 164,8 10,4% 10,1% Rare Disease 129,7 76,0 70,7% 71,3% 50,8 33,2 53,1% 54,4% Total Sales 2 495,9 2 309,1 8,1% 9,2% 836,6 772,4 8,3% 8,6% Highlights Total-sales growth in the year to date of 9.2% at CER1, or 8.1% as reported, with notable performances from Dysport® (abobotulinumtoxinA), Cabometyx® (cabozantinib) and Bylvay® (odevixibat), with robust Somatuline® (lanreotide) sales, as well as the increasing contribution from the launches of Iqirvo® (elafibranor) in 2L PBC2 and Onivyde® (irinotecan) in 1L mPDAC3 Regulatory approvals in the E.U. of Iqirvo and Kayfanda® (odevixibat)Increased 2024 financial guidance: total-sales growth greater than 8.0% at CER1 (prior guidance: greater than 7.0% at CER1); core operating margin greater than 31.0% of total sales (prior guidance: greater than 30.0%) “Since the launch of our strategy in 2020, we have enjoyed uninterrupted growth. This quarter was no exception and was accompanied by further progress in the pipeline”, commented David Loew, Chief Executive Officer. “We have also continued to launch across several indications and lines of therapy, including the recent rollouts of Iqirvo and Onivyde, which are progressing well. Supported by the performance so far this year, we are further increasing our 2024 sales and margin guidance.” “We have built a track record of delivery, grounded in a strong foundation of external innovation, commercial excellence and our ongoing mission to offer more choices for patients.” Full-year 2024 guidance Based on the strong performance in the third quarter, Ipsen has further increased its financial guidance for 2024: Total-sales growth greater than 8.0%, at constant currency (prior guidance of greater than 7.0%). Based on the average level of exchange rates in September 2024, an adverse impact on total sales of around 1.5% from currencies is expectedCore operating margin greater than 31.0% of total sales (prior guidance of greater than 30.0%) Pipeline update In September 2024, the European Commission conditionally approved Iqirvo 80mg tablets for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a monotherapy in patients unable to tolerate UDCA. Iqirvo was approved in the same setting by the U.S. FDA in June 2024. In September 2024, the European Commission also approved Kayfanda as a treatment for pruritus in children from as young as six months of age who have Alagille syndrome (ALGS). Odevixibat, under the brand name Bylvay, is already marketed in the E.U. for the treatment of progressive familial intrahepatic cholestasis (PFIC), and in the U.S. and E.U. for PFIC, and in the U.S. for ALGS. In the same month, final results from the CABINET Phase III trial were presented at the 2024 European Society for Medical Oncology Congress and were published in the New England Journal of Medicine, reinforcing the efficacy benefits of Cabometyx in advanced neuroendocrine tumors. It was announced at that time that Ipsen had submitted an extension of indication Marketing Authorization to the European Medicines Agency. Business development In August 2024, Ipsen entered into an agreement to sell its rare pediatric disease Priority Review Voucher. As part of the agreement, Ipsen received a cash payment of $158m in the third quarter. In October 2024, Eton Pharmaceuticals entered into an agreement with Ipsen to acquire Increlex® (mecasermin injection). The transaction is expected to close before the end of 2024. Arbitration proceedings with Galderma As of 30 September 2024, two arbitration proceedings initiated by Galderma against Ipsen at the International Chamber of Commerce (ICC) were ongoing. The first dispute, initiated by Galderma in 2021, pertains to the territorial scope of the commercial partnership related to Azzalure® (abobotulinumtoxinA) and Dysport under an agreement signed in 2007 in the E.U., in certain Eastern European countries, and in Central Asia. The Tribunal of the ICC Internal Court of Arbitration issued a final award, in October 2024, dismissing most, if not all, of Galderma's claims in this first arbitration and ordered that Galderma bear the majority of the legal fees and arbitration costs incurred by Ipsen. A second dispute was initiated by Galderma in November 2023, related to the validity of Ipsen’s 2023 termination of a joint R&D collaboration agreement entered into in 2014 under the parties’ respective early-stage neurotoxin programs, including the development of IPN10200. At this stage, Ipsen cannot reasonably predict any potential financial impact from this final remaining arbitration process, for which it intends to fully defend and vindicate its rights. Conference call A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its full-year and fourth-quarter results on 13 February 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2024 (YTD 2024) and the three-month period to 30 September 2024 (Q3 2024), compared to the nine-month period to 30 September 2023 (YTD 2023) and the three-month period to 30 September 2023 (Q3 2023), respectively. Commentary is based on the performance in YTD 2024, unless stated otherwise. About Ipsen Ipsen is a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fuelled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen contacts Investors Craig Marks +44 (0)7584 349 193 Nicolas Bogler +33 6 52 19 98 92 Media Jennifer Smith-Parker +44 (0) 7843 137 764Anne Liontas +33 7 67 34 72 96 1 At constant exchange rates (CER), which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 Second-line primary biliary cholangitis.3 First-line metastatic pancreatic ductal adenocarcinoma. Attachment Ipsen - YTD 2024 sales announcement