On July 31, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2024 and updated guidance for 2024 (Press release, Jazz Pharmaceuticals, JUL 31, 2024, View Source [SID1234645206]).

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"Jazz’s record revenues of over $1 billion in the second quarter were driven by strong execution and increased demand for our key growth drivers, Xywav, Epidiolex and Rylaze. Our launch preparations are well underway for zanidatamab, which was recently granted Priority Review in BTC, and we are pleased to have initiated the Phase 3 EmpowHER trial in HER2-positive breast cancer in patients whose disease has progressed after T-DXd treatment," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "Based on projections for the remainder of the year, we are narrowing and maintaining the mid-point of our Neuroscience guidance and lowering our Oncology guidance. Importantly, our Oncology guidance still includes double-digit growth at the mid-point and we continue to expect double-digit growth from our combined key growth drivers in 2024."

Key Highlights

•Key growth drivers:
◦Xywav net product sales grew 13% year-over-year.
◦Epidiolex/Epidyolex net product sales grew 22% year-over-year.
◦Rylaze/Enrylaze net product sales grew 6% year-over-year.
•Zanidatamab:
◦Granted Priority Review by U.S. FDA for 2L BTC; MAA validated by EMA.
◦Initiated Phase 3 EmpowHER trial in late-line HER2+ breast cancer.
•Near-term, late-stage pipeline catalysts anticipated:
◦Top-line data from Epidyolex Phase 3 trial in Japan in 2H24.
◦Top-line data from Zepzelca 1L SCLC Phase 3 trial by the end of 2024.
◦Top-line PFS data from zanidatamab in Phase 3 1L GEA estimated to be 2Q25.
•2024 Financial Guidance:
◦Narrowing 2024 total revenue guidance range to $4.0 to $4.1 billion.
◦Narrowing Neuroscience guidance to $2.825 to $2.925 billion.
◦Lowering Oncology guidance to $1.10 to $1.15 billion.
◦Affirming GAAP net income guidance of $385 to $530 million and non-GAAP adjusted net income guidance of $1.275 to $1.350 billion.1
◦Raising GAAP EPS guidance range by approximately $1.00 to $6.00 to $8.00 and non-GAAP EPS guidance to $19.20 to $20.30.
•Vision 2025: The Company is no longer providing the Vision 2025 metrics; however, the priorities highlighted in Vision 2025 remain the same:
◦Achieving commercial excellence to drive a growing and diversified revenue base;
◦Reaching more patients and creating value for shareholders by investing in our business and pipeline, including through corporate development; and
◦Maintaining disciplined capital allocation to generate long-term sustainable growth and value.

Business Updates

Key Commercial Products
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales were $368.5 million in 2Q24, an increase of 13% compared to the same period in 2023.
•There were approximately 13,225 active Xywav patients exiting 2Q24 comprised of:
◦Approximately 9,925 narcolepsy patients.
◦Approximately 3,300 idiopathic hypersomnia (IH) patients, with 250 net patient adds.
•As the only low-sodium oxybate and the only therapy approved to treat IH, expect Xywav to remain the oxybate of choice.
•Expert recommendations for optimizing flexible and individualized dosing regimens of low-sodium Xywav in narcolepsy and IH were published in Neurology and Therapy. Nearly 90% of HCPs surveyed felt the ability to adjust Xywav dosing to accommodate routine changes was important or very important and had a positive impact on their ability to provide care.
•Data presented at SLEEP 2024 included two late-breaking posters assessing the burden experienced by patients with IH. One poster demonstrated substantial comorbidity and health-related quality-of-life burdens for IH patients. Another poster reported greater economic burden, including work productivity impairment, compared to people living without IH.

Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
•Xyrem net product sales were $62.2 million in 2Q24, a decrease of 61% compared to the same period in 2023.
•Royalties from high-sodium oxybate AGs were $54.2 million in 2Q24, an increase of $48.7 million compared to the same period in 2023.
•The Company expects high-sodium oxybate AG royalty revenue to exceed $200 million in 2024.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales were $247.1 million in 2Q24, an increase of 22% compared to the same period in 2023.
•Outside of the U.S., Epidyolex is approved in more than 35 countries with additional launches and reimbursements anticipated through the end of 2024.
•A plain language summary of the BECOME survey results was published in Future Neurology. In addition to reporting an 85% reduction in the frequency of seizures, caregivers also reported improvements in non-seizure benefits such as cognitive, emotional and social functioning.
•Retrospective review of the validated REST-LGS questionnaire was evaluated in a real-world setting and the majority of patients who had not been previously diagnosed with Lennox-Gastaut syndrome (LGS) were identified, highlighting the potential of the screening tool to identify patients with LGS who may benefit from further diagnostic evaluation.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Rylaze/Enrylaze net product sales were $107.8 million in 2Q24, an increase of 6% compared to the same period in 2023.

Zepzelca (lurbinectedin):
•Zepzelca net product sales were $81.0 million in 2Q24, an increase of 15% compared to the same period in 2023.
•Enrollment in the Phase 3 trial evaluating first-line (1L) use of Zepzelca in combination with Tecentriq (atezolizumab) in small cell lung cancer (SCLC), in partnership with Roche, was completed in 1Q24.
•The Company expects top-line progression-free survival (PFS) data readout by the end of 2024.

Key Pipeline Highlights
Zanidatamab:
•In 2Q24, the U.S. FDA accepted and granted Priority Review of the Biologics License Application for zanidatamab with a target action date of November 29, 2024. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for biliary tract cancer (BTC) in the U.S. A confirmatory trial in 1L metastatic BTC is ongoing.
•The European Medicines Agency (EMA) validated the marketing authorization application (MAA) for zanidatamab in second-line (2L) BTC.
•Updated zanidatamab data from the HERIZON-BTC-01 trial were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024, demonstrating a confirmed objective response rate was maintained at 41.3%, median duration of response increased by approximately two months to 14.9 months compared to findings reported in 2023, and a median overall survival of 15.5 months in all patients with HER2+ BTC and 18.1 months in patients with immunohistochemistry (IHC) 3+ tumors.
•The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is ongoing and enrollment remains on track. Based on an updated blinded assessment of progression events, the Company estimates top-line PFS data will be available in 2Q25. The Company continues to track events in the trial relative to the initial protocol assumptions.
•The Company initiated the Phase 3 EmpowHER-BC-303 trial to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous trastuzumab deruxtecan (T-DXd) treatment.

Suvecaltamide (JZP385):
•Announced top-line results from the Phase 2b trial of suvecaltamide in essential tremor did not achieve statistical significance. The improvement in placebo from baseline to week 12 exceeded the Company’s expectations and was higher than what was observed for placebo in the prior T-CALM trial of suvecaltamide.
•A Phase 2 trial in patients with Parkinson’s disease tremor (PDT) is ongoing, with results expected 1Q25. The Company awaits results from the PDT trial to determine next steps, if any, for the program.

JZP441:
•Pending input from FDA, the Company is planning to initiate a Phase 1b trial of JZP441 in type 1 narcolepsy patients in 2H24.
•Expect this trial will further the Company’s understanding of JZP441 and more broadly orexin agonism, providing key learnings that could inform future development efforts.

Share Repurchases of Approximately $161 Million and New $500 Million Authorization
The Company resumed repurchases of its ordinary shares on the open market in the second quarter of 2024 as part of the Company’s previously authorized and announced share repurchase program. Under this share repurchase program, the Company was authorized to repurchase its ordinary shares for up to an aggregate purchase price of $1.5 billion, exclusive of any brokerage commissions. As of June 30, 2024, a nominal amount remained outstanding under this authorization, reflecting the purchase of shares worth approximately $161 million during the second quarter of 2024. The remaining amount will be utilized under the newly authorized repurchase program described below.

On July 25, 2024, the Board of Directors authorized a new share repurchase program with no expiration date pursuant to which the Company may repurchase its ordinary shares for up to an aggregate purchase price of $500 million, exclusive of any brokerage commissions. The timing and amount of repurchases under the program will depend on a variety of factors, including the amount and timing of corporate development transactions, repayment of debt, restrictions under the Company’s credit agreement, corporate and regulatory requirements, market conditions and the price of the Company’s ordinary shares.

Term Loan B Repricing
The Company completed a repricing of the approximately $2.7 billion outstanding balance of its U.S. dollar term loans under its credit facility. The applicable margin above the Term Secured Overnight Financing Rate was reduced by 75 basis points (from 300 basis points to 225 basis points) and the credit spread adjustment of approximately 11 basis points has also been removed, resulting in anticipated interest savings of approximately $23 million on an annualized basis. All other terms are substantially unchanged.

Irrevocable Election of Settlement Method for the 2.000% Exchangeable Senior Notes due 2026
Jazz Investments I Limited (the "Issuer"), a subsidiary of Jazz Pharmaceuticals, announced that it provided written notice to the exchange agent, the trustee and the holders of its 2.000% Exchangeable Senior Notes due 2026 (the "2026 notes") that it has irrevocably elected to fix the settlement method for exchanges of the 2026 notes to combination settlement with a specified cash amount equal to or in excess of $1,000. As a result, an exchanging holder will receive (i) up to $1,000 in cash per $1,000 principal amount of 2026 notes exchanged and (ii) cash, ordinary shares, or any combination thereof, at the Issuer’s election, in respect of the remainder, if any, of its exchange obligation in excess of $1,000 per $1,000 principal amount of 2026 notes exchanged.

Financial Highlights
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except per share amounts) 2024 2023 2024 2023
Total revenues $ 1,023,825 $ 957,317 $ 1,925,808 $ 1,850,129
GAAP net income $ 168,568 $ 104,438 $ 153,950 $ 173,858
Non-GAAP adjusted net income $ 364,727 $ 325,129 $ 546,942 $ 610,390
GAAP earnings per share $ 2.49 $ 1.52 $ 2.35 $ 2.55
Non-GAAP adjusted EPS $ 5.30 $ 4.51 $ 7.98 $ 8.46

GAAP net income for 2Q24 was $168.6 million, or $2.49 per diluted share, compared to $104.4 million, or $1.52 per diluted share, for 2Q23.
Non-GAAP adjusted net income for 2Q24 was $364.7 million, or $5.30 per diluted share, compared to $325.1 million, or $4.51 per diluted share, for 2Q23.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands) 2024 2023 2024 2023
Xywav $ 368,472 $ 326,564 $ 683,772 $ 604,325
Xyrem 62,180 159,769 126,412 337,899
Epidiolex/Epidyolex 247,102 202,226 445,818 391,135
Sativex 6,383 2,806 9,118 9,904
Total Neuroscience 684,137 691,365 1,265,120 1,343,263
Rylaze/Enrylaze 107,829 101,693 210,579 187,620
Zepzelca 81,047 70,348 156,147 137,529
Defitelio/defibrotide 45,421 46,108 93,097 85,187
Vyxeos 43,012 34,056 75,035 70,756
Total Oncology 277,309 252,205 534,858 481,092
Other 2,698 3,417 6,268 6,851
Product sales, net 964,144 946,987 1,806,246 1,831,206
High-sodium oxybate AG royalty revenue 54,164 5,514 104,111 7,610
Other royalty and contract revenues 5,517 4,816 15,451 11,313
Total revenues $ 1,023,825 $ 957,317 $ 1,925,808 $ 1,850,129

Total revenues increased 7% in 2Q24 compared to the same period in 2023.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $738.3 million in 2Q24, an increase of 6% compared to $696.9 million in 2Q23, primarily due to increased high-sodium oxybate AG royalty revenue and increased Epidiolex/Epidyolex and Xywav net product sales, partially offset by decreased Xyrem revenues.
Oncology net product sales were $277.3 million in 2Q24, an increase of 10% compared to the same period in 2023, and included higher net product sales from Zepzelca and Rylaze/Enrylaze, which increased 15% and 6% to $81.0 million and $107.8 million, respectively.

Operating Expenses and Effective Tax Rate
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except percentages) 2024 2023 2024 2023
GAAP:
Cost of product sales $ 109,902 $ 97,537 $ 205,389 $ 226,181
Gross margin 88.6% 89.7% 88.6% 87.6%
Selling, general and administrative $ 338,523 $ 340,844 $ 690,235 $ 638,761
% of total revenues 33.1% 35.6% 35.8% 34.5%
Research and development $ 220,734 $ 209,238 $ 443,581 $ 398,648
% of total revenues 21.6% 21.9% 23.0% 21.5%
Acquired in-process research and development $ — $ — $ 10,000 $ 1,000
Income tax benefit1
$ (30,653) $ (24,323) $ (18,984) $ (39,647)
Effective tax rate 1
(22.2)% (29.7)% (13.9)% (29.0)%

_________________________
1.The GAAP income tax benefit decreased in the six months ended June 30, 2024, compared to the same period in 2023, due to the change in income mix across our jurisdictions and the impact of tax shortfalls from share-based compensation.

Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except percentages) 2024 2023 2024 2023
Non-GAAP adjusted:
Cost of product sales $ 72,413 $ 65,994 $ 136,561 $ 130,722
Gross margin 92.5% 93.0% 92.4% 92.9%
Selling, general and administrative $ 303,386 $ 276,871 $ 614,885 $ 537,386
% of total revenues 29.6% 28.9% 31.9% 29.0%
Research and development $ 203,463 $ 192,019 $ 407,478 $ 365,937
% of total revenues 19.9% 20.1% 21.2% 19.8%
Acquired in-process research and development $ — $ — $ 10,000 $ 1,000
Income tax expense1
$ 23,520 $ 25,210 $ 89,316 $ 65,407
Effective tax rate1
6.1% 7.2% 14.0% 9.6%

_________________________
1.The non-GAAP income tax expense increased in the six months ended June 30, 2024, compared to the same period in 2023, due to the change in income mix across our jurisdictions and the impact of tax shortfalls from share-based compensation.

Changes in operating expenses in 2Q24 over the prior year period are primarily due to the following:
•Cost of product sales on a GAAP basis increased in 2Q24 compared to the same period in 2023 due to higher acquisition accounting inventory fair value step-up expense and changes in product mix. Cost of product sales on a non-GAAP adjusted basis increased in 2Q24 compared to the same period in 2023, due to changes in product mix.
•Selling, general and administrative (SG&A) expenses on a GAAP basis decreased in 2Q24 compared to the same period in 2023 primarily due to costs related to program terminations incurred in 2Q23. SG&A expenses on a GAAP and on a non-GAAP adjusted basis included increased investment in our priority programs in 2Q24 as compared to the same period in 2023.
•Research and development (R&D) expenses on a GAAP and on a non-GAAP adjusted basis increased in 2Q24 compared to the same period in 2023 primarily due to higher costs related to zanidatamab, as well as our other key pipeline programs.

Cash Flow and Balance Sheet
As of June 30, 2024, cash, cash equivalents and investments were $2.0 billion, and the outstanding principal balance of the Company’s long-term debt was $5.8 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million. For the six months ended June 30, 2024, the Company generated $598.6 million of cash from operations reflecting strong business performance and continued financial discipline.

2024 Financial Guidance
The Company is updating its full year 2024 financial guidance as follows:

(In millions) July 31, 2024 May 1, 2024
Revenues $4,000 – $4,100 $4,000 – $4,200
–Neuroscience (includes royalties from high-sodium oxybate AG)
$2,825 – $2,925 $2,800 – $2,950
–Oncology $1,100 – $1,150 $1,120 – $1,220

GAAP:
(In millions, except per share amounts and percentages) July 31, 2024 May 1, 2024
Gross margin % 89% 89%
SG&A expenses $1,366 – $1,426 $1,346 – $1,426
SG&A expenses as % of total revenues 33% – 36% 32% – 36%
R&D expenses $887 – $935 $877 – $935
R&D expenses as % of total revenues 22% – 23% 21% – 23%
Effective tax rate (22)% – (3)% (22)% – (3)%
Net income $385 – $530 $385 – $530
Net income per diluted share5
$6.00 – $8.00 $5.80 – $7.70
Weighted-average ordinary shares used in per share calculations 67 71

Non-GAAP:
(In millions, except per share amounts and percentages) July 31, 2024 May 1, 2024
Gross margin %
93%1,6
93%
SG&A expenses
$1,190 – $1,2302,6
$1,170 – $1,230
SG&A expenses as % of total revenues 29% – 31% 28% – 31%
R&D expenses
$810 – $8503,6
$800 – $850
R&D expenses as % of total revenues 20% – 21% 19% – 21%
Effective tax rate
10% – 12%4,6
10% – 13%
Net income
$1,275 – $1,3506
$1,275 – $1,350
Net income per diluted share5
$19.20 – $20.306
$18.15 – $19.35
Weighted-average ordinary shares used in per share calculations 67 71

Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. IST) to provide a business and financial update and discuss its 2024 second quarter results.
Audio webcast/conference call:
U.S. Dial-In Number: +1 800 715 9871
Ireland Dial-In Number: +353 1800 943 926
Additional global dial-in numbers are available here.
Passcode: 9124647

Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.

A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

On July 31, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported that it has entered into definitive securities purchase agreements for a registered direct offering of its common stock priced at-the-market under Nasdaq rules (Press release, IMUNON, JUL 31, 2024, View Source [SID1234645205]). In a concurrent private placement and also pursuant to the securities purchase agreements, the Company has agreed to issue to the investors unregistered warrants to purchase shares of common stock. Upon the closing of the offering, which is anticipated to occur on or about August 1, 2024, the Company expects to receive gross proceeds of $10 million, before deducting placement agent fees and other offering expenses payable by the Company. The closing of the offering is subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as the lead placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as co-placement agent.

Pursuant to the terms of the securities purchase agreements, the Company is selling an aggregate of 5,000,000 registered shares of its common stock, together with unregistered warrants to purchase up to 5,000,000 shares of its common stock, at a purchase price of $2.00 per share and accompanying warrant. The warrants will have an exercise price of $2.00 per share and will be exercisable immediately for a term of five and one-half years following the date of issuance.

The Company intends to use the net proceeds from the financing for working capital and general corporate purposes.

The shares of common stock offered in the registered direct offering are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-279425), including a base prospectus, previously filed with the Securities and Exchange Commission ("SEC") on May 15, 2024 and declared effective by the SEC on May 22, 2024. The offering of the shares of common stock to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the warrants in the private placement are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On July 31, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has entered into an option and license agreement for a potential first-in-class B7H3/PTK7 BsADC program with Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics (Press release, Ideaya Biosciences, JUL 31, 2024, View Source [SID1234645204]).

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"The potential first-in-class B7H3/PTK7 topo-I-payload BsADC program has the potential to be developed as a monotherapy agent in multiple solid tumor types, and advances IDEAYA’s broader corporate strategy to enable wholly-owned first-in-class rational combinations at the intersection of ADCs and small molecule DDR-based therapies to deliver greater benefit for patients," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"We are thrilled to announce our collaboration with IDEAYA to explore the promising combination of our potential first-in-class ADC and IDEAYA’s DDR small molecules," said Dr. Yuelei Shen, President and CEO of Biocytogen. "This partnership leverages our cutting-edge RenLite platform and proprietary linker-payload technology to enhance the precision and potency of ADCs. IDEAYA’s strong determination and rich experience in drug development make us confident that this therapy could be rapidly advanced to benefit patients."

The agreement grants IDEAYA an option for an exclusive worldwide license from Biocytogen for a potential first-in-class B7H3/PTK7 topo-I-payload BsADC program. B7H3/PTK7 has been found to be co-expressed in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, among others.

Under the terms of the agreement, Biocytogen will receive an upfront fee and upon an option exercise by IDEAYA, be entitled to receive an option exercise fee, development and regulatory milestones and commercial milestone payments, as well as single-digit royalties on net sales. Total potential upfront, option exercise and milestone payments equal an aggregate of $406.5 million, including development and regulatory milestones of $100.0 million.

Based on preclinical data, the potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program has the potential to be developed as a monotherapy agent and used in combination with multiple programs in IDEAYA’s pipeline targeting DDR-based therapies, including PARG inhibitor IDE161. A development candidate nomination for the B7H3/PTK7 topoisomerase-I-inhibitor payload BsADC program is targeted for the second half of 2024.

On July 31, 2024 HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:​HCM; HKEX:​13) reported its financial results for the six months ended June 30, 2024 and provides updates on key clinical and commercial developments (Press release, Hutchison China MediTech, JUL 31, 2024, View Source [SID1234645203]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, August 1, 2024. After registration, investors may access the live webcast via HUTCHMED’s website at www.hutch-med.com/event.

All amounts are expressed in US dollars unless otherwise stated.

Continued revenue momentum with substantial cash balance to support growth

Reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue of $300 to $400 million, with $168.7 million in the first half of 2024, driven by 59% (64% at CER[1]) oncology product revenue growth.
FRUZAQLA US in-market sales[2] of $130.5 million in the first half of 2024 – demonstrating strong demand and commercial traction since launch in November 2023.
Net income of $25.8 million in the first half of 2024. Cash balance of $802.5 million as of June 30, 2024, as we continued to prioritize key R&D[3] projects and enhance commercial efficiency.

Globalization of fruquintinib continues, broader pipeline makes strong progress

Preparation for EU launch of FRUZAQLA underway led by partner Takeda[4] after European Commission approval in June 2024 – Filings in over a dozen jurisdictions supported by FRESCO-2.
HUTCHMED preparing for China launch of sovleplenib for ITP[5] – potentially its first hematology medicine, after the NDA[6] was accepted and granted Priority Review status in January 2024.
Potential US NDA filing for savolitinib for NSCLC[7] at year end, based on SAVANNAH trial readout.
NDAs accepted to expand use of ORPATHYS and ELUNATE, and for TAZVERIK in China – for treatment-naïve METex14[8] NSCLC, endometrial cancer and follicular lymphoma, respectively.
Key late-stage registration trials initiated with 15 ongoing/under review – across six drug candidates: ESLIM-02 for sovleplenib in warm AIHA[9], RAPHAEL for HMPL-306 in AML[10], and for surufatinib in PDAC[11].
Growing hematology portfolio with new programs targeting Menin and CD38, joining the existing portfolio of inhibitors and antibodies targeting Syk[12], EZH2[13], IDH[14], BTK[15] and CD47.

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "HUTCHMED has delivered strong performance in the first half of this year. The team has made significant progress implementing our strategy in discovering and developing novel, effective medicines; conducting clinical trials in our home market and in the global markets; and rapidly advancing regulatory and commercial goals. I am very pleased with the ongoing success of our partnership with Takeda and with the growing ability of the Company to provide health benefits to patients overseas. We have grown our revenues from the US during this period and we expect to see revenue growth from many other countries in the coming months. We are also capitalizing on our proven track record of bringing new medicines and additional indications for our marketed medicines to China, with several potential NDA approvals for the next few years."

"I would like to take this opportunity to express my appreciation to Mr Simon To, my predecessor, who has recently retired. Mr To has stood at the cradle of HUTCHMED and has made a very significant contribution to grow the Company and turn it into a global innovative player, discovering, developing and commercializing therapies for the treatment of cancer and immunological diseases, improving the quality of life of patients around the world. I look forward to guiding the Company along its next phase of growth, which is full of potential and promise."

2024 Interim Results & Business Updates
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "The HUTCHMED team has been working tirelessly to continue the outstanding clinical and regulatory momentum that we have had in recent years, whilst importantly driving the commercial success of our approved products. I would like to extend my thanks to everyone for their hard work and commitment. Our oncology product revenue has grown 59% compared to the first half of 2023 and we are progressing a more focused R&D pipeline that has considerable potential for value creation. This year we initiated three key late-stage studies across our pipeline and are excited to be running over a dozen such studies that could support future drug approvals."

"The partnership strategy that we adopted for globalizing our medicines is allowing us to simultaneously fuel our in-house R&D engine, drive sales in our home market, and bring our medicines to patients in new geographies. Takeda’s impressive initial sales of FRUZAQLA demonstrates both the quality of our medicines and their potential across the globe and our strategy of working with partners outside of our home market."

"We expect to advance our registration trials in the second half of the year. Around year end, we anticipate the potential approval of sovleplenib in China and potential NDA filing of savolitinib in the US. We will continue to progress towards becoming a self-sustaining biopharma business."

I. COMMERCIAL OPERATIONS
Oncology in-market sales were up 140% (145% at CER) to $243.3 million (H1-23: $101.3m), which led to strong growth in consolidated oncology product revenue of 59% (64% at CER) to $127.8 million (H1-23: $80.1m), and mainly comprised of the following:

FRUZAQLA (fruquintinib ex-China) in-market sales were $130.5 million (H1-23: nil), which was launched in the US in November 2023. Its strong performance was due to rapid US patient uptake, as well as fulfilling sales channel inventory requirements;
ELUNATE (fruquintinib China) in-market sales increased 8% (13% at CER) to $61.0 million (H1-23: $56.3m), in line with CRC[16] market growth, maintaining our leading market share position while weathering greater market competition;
SULANDA (surufatinib) in-market sales increased 12% (17% at CER) to $25.4 million (H1-23: $22.6m), as doctors’ awareness continues to increase, leading to greater NET patient access and market share; and
ORPATHYS (savolitinib) in-market sales increased 18% (22% at CER) to $25.9 million (H1-23: $22.0m), as it benefited from improved testing and diagnosis for METex14 NSCLC and also ongoing growth momentum in the second year on the NRDL[17].

Oncology/​Immunology consolidated revenue comprised of consolidated oncology product revenue, which included product revenue, commercial service fees and royalties, as well as R&D income from our collaboration partners, mainly as follows:

Takeda upfront, milestones and R&D services revenue were $33.8 million (H1-23: $269.1m), which included recognition of $19.4 million of the $435.0 million upfront and milestone payments already received from Takeda in cash during 2023. This compared to recognition of $258.7 million in the first half of 2023.

As a result, total Oncology/Immunology consolidated revenue was $168.7 million (H1-23: $359.2m). Including Other Ventures revenue, total revenue was $305.7 million (H1-23: $532.9m).

II. REGULATORY UPDATES
China

Savolitinib sNDA[19] accepted by NMPA[20] for first-line and second-line METex14 NSCLC in 2024;
Fruquintinib approved in Hong Kong for third-line CRC in January 2024;
Fruquintinib sNDA accepted by NMPA with Priority Review for second-line endometrial cancer in early 2024;
Tazemetostat approved in Hong Kong for R/R[21] follicular lymphoma in May 2024; and
Tazemetostat NDA accepted by NMPA with Priority Review for R/R follicular lymphoma in July 2024.

Ex-China

Fruquintinib approved in the EU in June 2024, following positive opinion received from the EMA[22] Committee for Medicinal Products for Human Use for previously-treated metastatic CRC in April 2024.

III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET[23]

Completed enrollment of SAVANNAH (NCT03778229), a Fast Track-designated pivotal global Phase II study for NSCLC patients who have progressed following TAGRISSO due to MET amplification or overexpression, which may file in the US for accelerated approval. A small parallel study (NCT04606771) in this patient population presented data at AACR (Free AACR Whitepaper)[24] also demonstrated higher clinical activity with the combination therapy, with safety consistent with the known profiles of each treatment; and
Continued enrolling SAFFRON (NCT05261399), a global, pivotal Phase III study in this patient population of the TAGRISSO combination supporting SAVANNAH; SACHI (NCT05015608), a similar pivotal Phase III study for patients in China that progressed on EGFR[25] inhibitor treatment, and SANOVO (NCT05009836), a pivotal Phase III study for first-line patients in China with EGFR mutation & MET overexpression.
Potential upcoming clinical and regulatory milestones for savolitinib:

Complete enrollment of SACHI in late 2024; and
File FDA[26] NDA on SAVANNAH, subject to positive results, around year end 2024.

Fruquintinib (ELUNATE in China, FRUZAQLA outside of China), a highly selective oral inhibitor of VEGFR[27] 1/2/3 designed to have enhanced selectivity that limits off-target kinase activity

Presented results of FRUSICA-1, the registration Phase II study combined with sintilimab for patients with endometrial cancer with pMMR[28] status, which showed meaningful efficacy improvements regardless of prior bevacizumab treatment and a manageable toxicity profile (NCT03903705);
Presented FRESCO-2 subgroup analyses at ASCO (Free ASCO Whitepaper)[29], biomarker analysis at AACR (Free AACR Whitepaper) and quality-of-life analysis at ASCO (Free ASCO Whitepaper) GI[30] (NCT04322539). Analyses showed that the treatment was effective regardless of prior therapy or sequence, that CEA[31] response may be an early predictor of improved efficacy, and that it demonstrated clinically meaningful quality-adjusted survival benefit in patients with previously-treated CRC; and
Published in Nature Medicine the results of FRUTIGA, the study combined with paclitaxel for gastric cancer patients in China, concurrently with ASCO (Free ASCO Whitepaper) and following initial presentation at ASCO (Free ASCO Whitepaper) Plenary (NCT03223376). PFS[32], ORR[33] and DCR[34] showed statistically significant improvements, and although OS[35] improvement was not statistically significant overall, it was statistically significant in a pre-specified analysis excluding patients taking subsequent antitumor therapy.
Potential upcoming clinical and regulatory milestones for fruquintinib:

Complete PMDA[36] NDA review for previously-treated metastatic CRC in late-2024; and
Announce top-line results from the FRUSICA-2 Phase II/III registration trial in clear cell RCC[37] around year end if the requisite number of PFS events is reached (NCT05522231).

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and B-cell receptor signaling pathways

Published ESLIM-01 (NCT05029635) results in adult patients with primary ITP in China inLancet Haematology concurrently with presentations at EHA (Free EHA Whitepaper)[38]. In addition to demonstrating a clinically meaningful early and sustained durable response of 48.4% and a tolerable safety profile, it significantly improved quality of life and showed consistent clinical benefits regardless of prior lines of therapies, prior TPO/TPO-RA[39] exposure or treatment types;
Published results of the Phase II proof-of-concept stage of a study in patients with warm AIHA in China at EHA (Free EHA Whitepaper), demonstrating a favorable safety profile and encouraging hemoglobin benefits; and
Initiated ESLIM-02, the Phase III stage of the study, as a result of this positive data (NCT05535933).
Potential upcoming clinical milestones for sovleplenib:

Initiate a dose-finding study in ITP in the US/EU in mid-2024 (NCT06291415); and
Complete ESLIM-01 NMPA NDA review around year end.

Surufatinib (SULANDA in China), an oral inhibitor of VEGFR, FGFR[40] and CSF-1R[41] designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation

Initiated a Phase II/III trial for treatment-naïve metastatic PDAC in China, in combination with PD-1[42] antibody camrelizumab, nab-paclitaxel and gemcitabine (NCT06361888). This study was informed in part by an investigator-initiated trial presented at ASCO (Free ASCO Whitepaper) GI 2024 of a similar combination. This highly aggressive form of cancer has an estimated 511,000 people diagnosed annually worldwide.

Tazemetostat (TAZVERIK in Hainan, Macau and Hong Kong), a first-in-class, oral inhibitor of EZH2

Potential to complete China NDA review for R/R follicular lymphoma in mid-2025.

HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

Continued enrolling the registrational Phase II trial for IHCC[43] with FGFR 2 fusion (NCT04353375).

HMPL-306, an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes, which have been implicated as drivers of certain hematological malignancies, gliomas and solid tumors

Presented results from China and US/European Phase I studies at EHA (Free EHA Whitepaper), showing it as an effective treatment for IDH1 and/or IDH2-mutated R/R AML (NCT04272957, NCT04764474); and
Initiated RAPHAEL Phase III Trial for IDH1- and/or IDH2-mutated R/R AML in China (NCT06387069).

Other early-stage investigational drug candidates

Presented preclinical and Phase I results at AACR (Free AACR Whitepaper), ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) for ERK1/2[44] inhibitor HMPL-295, third-generation BTK inhibitor HMPL-760, Menin inhibitor HMPL-506, and CD38 ADC[45] HMPL-A067; and
Initiated Phase I trial for HMPL-506 for hematological malignancies in China (NCT06387082).

IV. COLLABORATION UPDATES
Further clinical progress by Inmagene[46] with two candidates discovered by HUTCHMED

Received approximately 7.5% of shares (fully diluted) in Inmagene following exercise of its option for an exclusive license to further develop, manufacture and commercialize IMG-007, a nondepleting anti-OX40 antibody, and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor;
Inmagene announced positive interim results from a Phase IIa trial of IMG-007 for atopic dermatitis. Treatment led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis, while remaining well-tolerated overall. Final results are anticipated later in the third quarter of 2024. Inmagene also completed enrollment of a Phase IIa trial for alopecia areata; and
Inmagene announced positive topline results of a multiple ascending dose study with IMG-004, indicating once daily dosing potential. It was well tolerated, without reports of liver enzyme elevation or bleeding events, across once daily doses ranges for 10 days. Preliminary modeling and data support 50mg once daily as a potential therapeutic dose and further development as a differentiated treatment for BTK-mediated immunological diseases.

V. OTHER VENTURES
Other Ventures revenue is predominantly from our prescription drug distribution operation in China. Consolidated revenue decreased by 21% (18% at CER) to $137.0 million (H1-23: $173.7m) primarily as a result of lower COVID-related prescription drug distribution sales in 2024.
SHPL[47], a non-consolidated joint venture, saw revenue decrease by 4% (flat at CER) to $225.2 million (H1‑23: $235.3m) mainly due to pricing reduction in a few higher-priced provinces to standardize the pricing structure of MUSKARDIA in preparation for potential national implementation of volume-based procurement.
Consolidated net income attributable to HUTCHMED from our Other Ventures decreased by 8% (4% at CER) to $34.1 million (H1-23: $37.2m), which was primarily due to decrease on the net income contributed from SHPL of $33.8 million (H1-23: $35.1m) as a result of price reduction impact from volume-based procurement, as well as increase in R&D spending.
We continue to explore opportunities to monetize the underlying value of our SHPL joint venture including various divestment and collaboration alternatives.

VI. SUSTAINABILITY
HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders. In April 2024, we published our 2023 Sustainability Report, which highlighted progress made in our 11 goals and targets; our enhanced climate actions including Scope 3 emissions screening and measurement and engaging with suppliers; our enhanced data quality; our strengthened alignment of our five most relevant and material sustainability pillars; and our enhanced disclosure and sector specific disclosure standards ahead of requirement.

Wider recognition of HUTCHMED’s efforts have been reflected in steady improvements in major local and international sustainability ratings including from Hang Seng, ISS, MSCI, S&P Global, Sustainalytics and Wind. Recently, HUTCHMED scored 49 for S&P Global ESG[48] Ratings, significantly higher than the industry average of 31. HUTCHMED also received the Best ESG(E) at the Hong Kong Investor Relations Association’s 10th Investor Relations Awards, two awards at Bloomberg Businessweek’s ESG Leading Enterprises event, five awards from Metro Finance’s GBA ESG Achievement Awards, and was listed amongst the Top 20 Chinese Pharmaceutical Listed Companies in ESG Competitiveness by Healthcare Executive.

In 2024, we continue our efforts on the above areas and further strengthening our climate action by conducting a more comprehensive climate risk assessment to quantify the impact of climate risks in our major operations; incorporate sustainability into our corporate culture; and considering future goals and targets.

Financial Highlights
Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 4% during the first half of 2024, which has impacted our consolidated financial results as highlighted below.

Cash, Cash Equivalents and Short-Term Investments were $802.5 million as of June 30, 2024 compared to $886.3 million as of December 31, 2023.
Adjusted Group (non-GAAP[49]) net cash flows excluding financing activities in the first half of 2024 were ‑$51.3 million (H1-23: $219.3m), mainly due to $39.8 million net cash used in operating activities and $10.1 million of capital expenditure; and
Net cash used in financing activities in the first half of 2024 totaled $32.6 million due to purchases for equity awards of $36.1 million (H1-23: net cash generated from financing activities of $5.8m).

Revenue for the six months ended June 30, 2024 was $305.7 million compared to $532.9 million in the six months ended June 30, 2023.
Oncology/Immunology consolidated revenue amounted to $168.7 million (H1-23: $359.2m) from:
FRUZAQLA revenue was $42.8 million, reflecting its successful US launch since early November 2023, comprising royalties and manufacturing revenue;
ELUNATE revenue increased 9% (14% at CER) to $46.0 million (H1-23: $42.0m) in its sixth year since launch, comprising of manufacturing revenue, promotion and marketing service revenue and royalties, which is in line with CRC market growth, maintaining our leading market share position while weathering greater market competition;
SULANDA revenue increased 12% (17% at CER) to $25.4 million (H1-23: $22.6m) continued sales growth after NRDL renewal as doctors’ awareness continues to increase, leading to greater NET patient access and market share;
ORPATHYS revenue decreased 14% (10% at CER) to $13.1 million (H1-23: $15.1m), due to a reduction in manufacturing revenue to $5.3 million (H1-23: $8.5m), offset by an increase in royalties to $7.8 million (H1-23: $6.6m) reflecting strong in-market sales growth of 18% (22% at CER);
TAZVERIK revenue was $0.5 million (H1-23: $0.4m) mainly from sales in the Hainan Pilot Zone[50];
Takeda upfront, milestones and R&D services revenue decreased to $33.8 million (H1-23: $269.1m, of which $258.7m was the recognized portion of the $400 million upfront cash payment received from Takeda in April 2023); and
Other R&D services revenue of $7.1 million (H1-23: $10.0m), primarily related to fees from AstraZeneca and Lilly for the management of development and regulatory activities.
Other Ventures consolidated revenue decreased 21% (18% at CER) to $137.0 million (H1-23: $173.7m), primarily as a result of lower COVID-related prescription drug distribution sales in 2024. This excluded non‑consolidated revenue at SHPL of $225.2 million (H1-23: $235.3m).

Net Expenses for the six months ended June 30, 2024 were $279.9 million compared to $364.3 million in the six months ended June 30, 2023, reflecting our strong efforts on cost control.
Cost of Revenue decreased by 14% to $180.1 million (H1-23: $208.3m), which was the net result of a reduction in cost of revenue from our Other Ventures, offset by the increase in product sales of our marketed products and the cost of promotion and marketing services for ELUNATE resulting from the increased sales force;
R&D Expenses reduced 34% to $95.3 million (H1-23: $144.6m), mainly due to the strategic prioritization of our pipeline, particularly outside China. Clinical and regulatory expenses in the US and Europe were $14.9 million (H1-23: $55.6m), while R&D expenses in China were $80.4 million (H1-23: $89.0m);
S&A[51] Expenses were $57.8 million (H1-23: $68.3m), which decreased primarily due to tighter control over our spending, while utilizing existing infrastructure to support further revenue growth; and
Other Items mainly comprised of equity in earnings of SHPL, interest income and expense, FX and taxes, generated net income of $53.3 million (H1-23: $56.9m), which decreased primarily due to lower foreign currency exchange gains recognized in the period.

Net Income attributable to HUTCHMED for the six months ended June 30, 2024 was $25.8 million compared to $168.6 million for the six months ended June 30, 2023.
The net income attributable to HUTCHMED for the six months ended June 30, 2024 was $0.03 per ordinary share / $0.15 per ADS[52], (H1-23: $0.20 per ordinary share / $1.00 per ADS).

FINANCIAL GUIDANCE
We reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue is $300 million to $400 million, driven by 30% to 50% growth target in oncology marketed product revenue. HUTCHMED’s work in 2024 and beyond will be supported by its strong balance sheet. The Company is thus well placed to deliver against its target to become a self-sustaining business and its goal to bring its innovative medicines to patients globally through its own sales network in China markets and through partners worldwide.

Shareholders and investors should note that:

we do not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and
we have in the past revised our financial guidance and reference should be made to any announcements published by us regarding any updates to the financial guidance after the date of publication of this announcement.
———

Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

Financial Summary
Condensed Consolidated Balance Sheets Data

Condensed Consolidated Statements of Operations Data

On July 31, 2024 GSK reported continued strong performance and upgrades 2024 guidance (Press release, GlaxoSmithKline, JUL 31, 2024, View Source [SID1234645202]).

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Broad-based performance drives sales, core profit and core EPS growth:

Total Q2 2024 sales £7.9 billion +13%
Vaccines sales +1%, +3% ex COVID. Shingrix £0.8 billion -4%
Specialty Medicines sales +22%. HIV sales +13%. Oncology sales more than doubled at £0.4 billion
General Medicines sales +12%. Trelegy £0.8 billion +41%
Total operating profit -22% and Total EPS -27% for Q2 2024 primarily reflected higher charges for CCL(1) remeasurements driven by improved longer term HIV prospects and foreign currency movements
Core operating profit +18% (with further positive impact of 3% ex COVID) and Core EPS +13% (with further positive impact of 4% ex COVID). This reflected continued leverage from strong sales and favourable product and regional mix, partly offset by continued increased investment in R&D and growth assets, and lower royalty income
Cash generated from operations in the quarter £1.7 billion with Free cash flow of £0.3 billion
Q2 2024 Year to date
£m % AER % CER £m % AER % CER
Turnover 7,884 10 13 15,247 8 12
Turnover ex COVID 7,884 10 13 15,246 9 13
Total operating profit 1,646 (23) (22) 3,136 (26) (20)
Total operating margin % 20.9% (8.9ppts) (9.1ppts) 20.6% (9.3ppts) (8.4ppts)
Total EPS 28.8p (28) (27) 54.5p (29) (24)
Core operating profit 2,513 16 18 4,956 16 22
Core operating margin % 31.9% 1.6ppts 1.3ppts 32.5% 2.3ppts 2.9ppts
Core EPS 43.4p 12 13 86.5p 14 20
Cash generated from operations 1,650 2 2,776 46
Continued R&D progress with growth prospects strengthened in all key therapeutic areas:
Infectious Diseases: FDA approval for Arexvy in adults aged 50-59 at increased risk from RSV; filings accepted for meningitis (ABCWY) vaccine
HIV: regimen selection for CAB-ULA, and data for new 3rd generation integrase inhibitor, support portfolio progression and long-term growth outlooks
Respiratory/Immunology: Pivotal data for depemokimab (SWIFT 1/2) support filings as first ultra-long-acting biologic for severe asthma
Oncology: Pivotal data for Blenrep (DREAMM-8) support regulatory submissions (EU filed; US H2 2024). Data supporting expanded use of Jemperli in patients with endometrial cancer presented (regulatory decisions expected H2 2024). Approval for Omjjara received in Japan
2024 guidance upgraded; Q2 2024 dividend of 15p declared continue to expect 60p full year dividend:
2024 turnover growth increase of 7% to 9% (previously 5% to 7%); Core operating profit growth of 11% to 13% (previously 9% to 11%); Core EPS growth of 10% to 12% (previously 8% to 10%)
Q2 2024 results infographic view summary of results for details
Emma Walmsley, Chief Executive Officer, GSK:
"GSK’s momentum this year continues with excellent second quarter performance, reflecting strong operational execution and the strengthening breadth of our portfolio to both prevent and treat disease. Q2 sales grew in all areas, with Specialty Medicines in particular benefitting from new product launches in oncology and HIV. In R&D, so far this year, we have secured approvals or filings for 10 major opportunities and reported positive data from 7 phase III trials. We have also strengthened capabilities in key technology platforms and completed investments to develop new mRNA vaccines, ultra-long-acting HIV medicines and a promising new medicine for severe asthma. All this supports our future growth and confidence to bring meaningful innovation to patients".

Assumptions and cautionary statement regarding forward-looking statements
The Group’s management believes that the assumptions outlined above are reasonable, and that the guidance, outlooks, and expectations described in this report are achievable based on those assumptions. However, given the forward-looking nature of these guidance, outlooks, and expectations, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macro-economic activity, the impact of outbreaks, epidemics or pandemics, changes in legislation, regulation, government actions or intellectual property protection, product development and approvals, actions by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, "forward-looking statements". Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, dividend payments and financial results. Other than in accordance with its legal or regulatory obligations (including under the Market Abuse Regulation, the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements.

All guidance, outlooks and expectations should be read together with the guidance and outlooks, assumptions and cautionary statements in this Q2 2024 earnings release and in the Group’s 2023 Annual Report on Form 20-F.