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 Ono reported consolidated Financial Results for the First Quarter of the Fiscal Year Ending March 31, 2025 (IFRS) (Filing, 3 mnth, JUN 30, Ono, 2024, JUL 31, 2024, View Source [SID1234646142]).

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On July 31, 2024 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the second quarter and first half of 2024 (Press release, Qiagen, JUL 31, 2024, View Source [SID1234645207]).

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Net sales were stable at $496 million in Q2 2024 compared to Q2 2023, while results at constant exchanges rates (CER) of $502 million rose 1% and were above the outlook for at least $495 million CER. The adjusted operating income margin rose about one percentage point to 28.4% from Q2 2023 on efficiency gains while supporting targeted investments. Adjusted diluted earnings per share (EPS) were $0.55, and results at CER of $0.55 were above the outlook for at least $0.52 CER.

QIAGEN has updated its FY 2024 outlook based on the solid core business performance in the first half of the year, which was about $15 million CER above guidance, as well as the decision to phase out the NeuMoDx clinical PCR system. As a result, total net sales are expected to be at least $1.985 billion CER and includes a $30 million CER adjustment in expected NeuMoDx sales for 2024.

The outlook for adjusted diluted EPS has been increased to at least $2.16 CER, while the adjusted operating income margin target is for at least 28.5% compared to 26.9% in 2023.

"Our teams executed well in the second quarter, showing sequential growth from the first quarter as well as over the year-ago period as we accelerate our performance during 2024. We are on track to achieve our updated outlook that reflects the strong trends in our core business along with the decision on the NeuMoDx system," said Thierry Bernard, CEO of QIAGEN.

"We are strengthening our portfolio with new product launches, particularly for QIAstat-Dx with the FDA 510(k) clearances of the new gastrointestinal panel and the updated respiratory panel. As we head into the second half of 2024, we continue to expect solid growth trends in our core business and are well-positioned to deliver on our commitments for 2024," Bernard said.

"QIAGEN again delivered growth ahead of our outlook for the second quarter of 2024 that gives us renewed confidence in achieving the updated outlook for sales and adjusted earnings for 2024," said Roland Sackers, Chief Financial Officer of QIAGEN. "We are seeing the benefits of our initiatives to improve profitability, as we confirm our full-year target for an adjusted operating income margin of at least 28.5%, combined with higher free cash flow. These improvements put us on a trajectory to achieve the targets we have set for 2028 as part of our commitment to solid profitable growth."

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is planned for Thursday, August 1, 2024 at 15:00 Frankfurt Time / 14:00 London Time / 9:00 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a recording will also be made available after the event.
A presentation will be available before the conference call at View Source

Use of adjusted results

QIAGEN reports adjusted results, as well as results on a constant exchange rate (CER) basis, and other non-U.S. GAAP figures (generally accepted accounting principles), to provide additional insight into its performance. These results include adjusted net sales, adjusted gross income, adjusted gross profit, adjusted operating income, adjusted operating expenses, adjusted operating income margin, adjusted net income, adjusted net income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted EPS, adjusted income taxes, adjusted tax rate, and free cash flow. Free cash flow is calculated by deducting capital expenditures for Property, Plant & Equipment from cash flow from operating activities. Adjusted results are non-GAAP financial measures that QIAGEN believes should be considered in addition to reported results prepared in accordance with GAAP but should not be considered as a substitute. QIAGEN believes certain items should be excluded from adjusted results when they are outside of ongoing core operations, vary significantly from period to period, or affect the comparability of results with competitors and its own prior periods. Furthermore, QIAGEN uses non-GAAP and constant currency financial measures internally in planning, forecasting and reporting, as well as to measure and compensate employees. QIAGEN also uses adjusted results when comparing current performance to historical operating results, which have consistently been presented on an adjusted basis.

On July 30, 2024 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Arvinas, JUL 30, 2024, View Source [SID1234645147]).

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"During the second quarter, we continued making meaningful progress across our entire portfolio, with upcoming milestones that will further support our mission to improve patient lives with pioneering therapies from our revolutionary PROTAC protein degradation platform," said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. "The readout of VERITAC-2, our first Phase 3 clinical trial, will be a landmark event for Arvinas. We are on-track to complete enrollment in the fourth quarter of the year, with topline data anticipated in either the fourth quarter of 2024 or first quarter of 2025. If positive, we believe these results will support our first new drug application filing and our transition to a commercial-stage company, assuming regulatory approval."

"We are well on our way to becoming a multi-product, commercial-stage organization with strong leadership and a robust pipeline across several indications," continued Dr. Houston. "Our first PROTAC degrader with the potential to treat neurodegenerative diseases, ARV-102, was recently cleared to initiate the multiple ascending dose portion of our Phase 1 clinical trial. In addition, we initiated the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with our PROTAC BCL6 degrader ARV-393. I’m excited by the progress we have made and the ongoing confidence we have in our PROTAC platform, which was further validated by our recent strategic transaction with Novartis. We believe Novartis will accelerate and broaden the development of ARV-766 as a potential best-in-class treatment for patients with prostate cancer."

Recent Developments and 2Q Business Highlights

Vepdegestrant

Evaluated enrollment and blinded event rates in the ongoing VERITAC-2 Phase 3 monotherapy clinical trial (NCT05654623) in patients with metastatic breast cancer.
The trial is on track to complete enrollment in 4Q24.
Based on current trial status, the primary completion date has been reprojected to November 2024, with topline data now anticipated in 4Q24/1Q25.
Completed enrollment of the study lead-in for the VERITAC-3 Phase 3 clinical trial of vepdegestrant in combination with palbociclib as a first-line treatment in patients with estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer.
Continued enrollment globally in multiple clinical studies of vepdegestrant in ER+/HER2- metastatic breast cancer.
Presented updated clinical data from a Phase 1b clinical trial combination cohort evaluating vepdegestrant in combination with palbociclib in heavily pre-treated patients with locally advanced or metastatic ER+/HER2- breast cancer at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress.
After six months of additional follow-up, updated data from the trial continued to demonstrate an encouraging clinical benefit rate, objective response rate and progression-free survival, and a consistent safety profile as previously reported at the San Antonio Breast Cancer Symposium (SABCS) in December 2023.
The clinical benefit rate across all dose levels (n=46) was 63%; the objective response rate in evaluable patients with measurable disease at baseline (n=31) was 42%; median progression-free survival based on 27 (59%) events across all dose levels was 11.2 months (95% CI: 8.2 – 16.5) and the safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023.
Patients receiving the recommended Phase 3 dose of vepdegestrant (200mg) in combination with palbociclib 125mg (n=21), achieved a median progression-free survival of 13.9 months (95% CI: 8.1-NR).
Strategic Transaction with Novartis

Entered into a license agreement and asset purchase agreement with Novartis (NYSE: NVS) for the exclusive, worldwide development, manufacture and commercialization of ARV-766, Arvinas’ second generation PROTAC androgen receptor (AR) degrader for patients with prostate cancer, and the sale of Arvinas’ preclinical AR-V7 program, which closed on May 28, 2024.
Arvinas received a one-time, upfront payment in the aggregate amount of $150.0 million in accordance with the terms of the license agreement and the asset purchase agreement. Under the terms of the license agreement, Arvinas is also eligible to receive up to an additional $1.01 billion as contingent payments based on specified development, regulatory, and commercial milestones for ARV-766 being met, as well as tiered royalties based upon worldwide net sales of ARV-766.
Pipeline

ARV-102: Oral PROTAC LRRK2 degrader

Presented preclinical data at the Biennial International LRRK2 Meeting further supporting the potential of PROTAC-induced leucine-rich repeat kinase 2 (LRRK2) degradation as a potential treatment for neurodegenerative diseases. Key findings included:
With Arvinas’ PROTAC LRRK2 degrader, near-complete LRRK2 target engagement, as well as LRRK2 degradation, in mouse and non-human primate lung and brain.
Differing effects of the LRRK2 PROTAC degraders in the lungs compared to kinase inhibitors, suggesting reduced pulmonary function risk.
Substantially less Type II pneumocyte enlargement compared to MLi-2, an experimental LRRK2 kinase inhibitor.
Surfactant protein accumulation in mouse lung observed after treatment with the LRRK2 kinase inhibitor MLi-2, but not after treatment with the PROTAC LRRK2 degrader.
No evidence of collagen deposition in lung to date with PROTAC LRRK2 degraders in non-human primates.
Received health authority approval to initiate the multiple ascending dose portion of the ongoing Phase 1 clinical trial in healthy volunteers with the PROTAC LRRK2 degrader ARV-102.
ARV-393: Oral PROTAC BCL6 degrader

Presented preclinical data for ARV-393 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Annual Congress that showed ARV-393:
Potently and rapidly degraded the BCL6 protein and inhibited cell growth in diffuse large B-cell lymphoma (DLBCL) and Burkitt cell lines.
Showed tumor growth inhibition, including tumor regression, in various DLBCL cell line-derived xenograft (CDX) models and in multiple patient-derived xenograft (PDX) models of non-Hodgkin lymphoma (NHL), including germinal center B-cell-like (GCB), activated B-cell (ABC), GCB/ABC, BCL not otherwise specified (BCL/NOS) subtypes of DLBCL, and Burkitt lymphoma.
Initiated the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with PROTAC BCL6 degrader ARV-393.
Corporate

Announced the appointment of Andrew Saik, MBA, to the role of Chief Financial Officer.
Announced the promotion of Ian Taylor, Ph.D., to President of Research and Development.
Announced the promotion of Angela Cacace, Ph.D., to Chief Scientific Officer.
Announced the promotion of Randy Teel, Ph.D., to Chief Business Officer.
Anticipated Upcoming Milestones and Expectations

Vepdegestrant (ARV-471)
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

Complete enrollment (4Q24) and announce topline data (4Q24/1Q25) for the VERITAC-2 Phase 3 monotherapy clinical trial.
Evaluate data from the study lead-in of the VERITAC-3 Phase 3 trial to support dose selection for vepdegestrant plus palbociclib in planned Phase 3 combination trials in patients with ER+/HER2- locally advanced or metastatic breast cancer (2H24).
Present initial safety and pharmacokinetic data from the abemaciclib arm of the ongoing TACTIVE-U trial (2H24).
Continue enrollment of the ongoing Phase 1b/2 combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (TACTIVE-U; ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and NCT06125522).
Continue enrollment and evaluate preliminary data from the ongoing clinical trial with vepdegestrant plus Pfizer’s novel CDK4 inhibitor atirmociclib (TACTIVE-K; ClinicalTrials.gov Identifier: NCT06206837) to inform the study design for the planned Phase 3 first line combination trial with either atirmociclib or palbociclib, with planned initiation in 2025.
Pipeline

Continue enrollment in the single ascending dose portion of the Phase 1 clinical trial in healthy volunteers with the PROTAC LRRK2 degrader ARV-102 and begin enrolling the multiple ascending dose portion by the end of 2024.
Continue enrollment in the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with PROTAC BCL6 degrader ARV-393.
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of June 30, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027.

Second Quarter Financial Results
Cash, Cash Equivalents, Restricted Cash and Marketable Securities Position: As of June 30, 2024, cash, cash equivalents, restricted cash and marketable securities were $1,234.2 million as compared with $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents, restricted cash and marketable securities of $32.3 million for the six months ended June 30, 2024 was primarily related to cash used in operations of $36.0 million (net of $150.0 million received from the Novartis agreements), unrealized losses on marketable securities of $0.7 million and the purchase of lab equipment and leasehold improvements of $0.8 million, partially offset by proceeds from the exercise of stock options of $5.3 million.

Research and Development Expenses: Research and development expenses were $93.7 million for the quarter ended June 30, 2024, as compared with $103.4 million for the quarter ended June 30, 2023. The decrease in research and development expenses of $9.7 million for the quarter was primarily due to decreases in expenses related to our ER program (which includes the cost sharing of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer) of $6.6 million and our platform and exploratory programs of $5.7 million, partially offset by an increase in our AR program (which includes ARV-766 and bavdegalutamide (ARV-110)) of $2.6 million.

General and Administrative Expenses: General and administrative expenses were $31.3 million for the quarter ended June 30, 2024, as compared with $25.7 million for the quarter ended June 30, 2023. The increase in general and administrative expenses of $5.6 million for the quarter was primarily due to an increase in personnel and infrastructure related costs of $4.0 million and professional fees of $1.6 million.

Revenues: Revenues were $76.5 million for the quarter ended June 30, 2024, as compared with $54.5 million for the quarter ended June 30, 2023. Revenue for the quarter is related to the license agreement and the asset purchase agreement with Novartis, the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the collaboration and license agreement with Bayer, the collaboration and license agreement with Pfizer, and revenue related to our Oerth Bio joint venture. The increase in revenue of $22.0 million was primarily due to revenue from the Novartis agreements, which were entered into during the quarter, of $45.4 million, offset by a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $22.2 million and a decrease of $1.3 million of previously constrained deferred revenue related to our Oerth Bio joint venture.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.

The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.

On July 30, 2024 Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2024 and raised its full-year 2024 guidance(1) for both Revenues and Adjusted(2) diluted EPS (Press release, Pfizer, JUL 30, 2024, View Source [SID1234645167]).

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The second-quarter 2024 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.

EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: "We are driving progress toward our 2024 strategic priorities through solid execution across the company. I am pleased with the strong performance of our product portfolio in the second quarter led by several of our acquired products, key in-line brands and recent commercial launches. Notably, we achieved exceptional growth in our Oncology portfolio, with strong revenue contribution from our legacy-Seagen products.

"Overall, I am encouraged by our performance in the first half of 2024 and we remain focused on making a difference in the lives of patients as we continue to advance and strengthen our company."
David Denton, Chief Financial Officer and Executive Vice President, stated: "This was Pfizer’s first quarter of topline revenue growth, on a year-over-year basis, since the fourth quarter of 2022 when our COVID revenues peaked. Importantly, the strong 14% operational revenue growth of our non-COVID products in the second quarter demonstrates our continued focus on commercial execution. In support of our stated strategic priority to realign our cost base, we continue to progress our cost realignment program. Additionally, with our more recent announcement of the first phase of our Manufacturing Optimization Program, we believe we are setting the foundation for future margin expansion."

OVERALL RESULTS

In the first quarter of 2024, Pfizer reclassified royalty income (substantially all of which is related to our Biopharma segment) from Other (income)/deductions––net to revenues and began presenting Royalty revenues as a separate line item within Total revenues in our consolidated statements of operations. Prior-period amounts have been recast to conform to the current presentation.
At the beginning of 2024, Pfizer made changes in our commercial organization to incorporate Seagen Inc. (Seagen) and improve focus, speed and execution. Specifically, within our Biopharma reportable segment Pfizer created the Pfizer Oncology Division, the Pfizer U.S. Commercial Division, and the Pfizer International Commercial Division. See the Item 1. Business––Commercial Operations section of Pfizer’s 2023 Annual Report on Form 10-K (available at www.pfizer.com).
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(7).
Results for the second quarter and first six months of 2024 and 2023(8) are summarized below.
($ in millions, except
per share amounts) Second-Quarter Six Months
2024 2023 Change 2024 2023 Change
Revenues $ 13,283 $ 13,007 2% $ 28,162 $ 31,492 (11%)
Reported(4) Net Income
41 2,327 (98%) 3,156 7,870 (60%)
Reported(4) Diluted EPS
0.01 0.41 (98%) 0.55 1.38 (60%)
Adjusted(2) Income
3,400 3,839 (11%) 8,074 10,876 (26%)
Adjusted(2) Diluted EPS
0.60 0.67 (11%) 1.42 1.90 (25%)

REVENUES
($ in millions) Second-Quarter Six Months
2024 2023 % Change 2024 2023 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 12,991 $ 12,690 2% 4% $ 27,595 $ 30,863 (11%) (10%)
Pfizer CentreOne (PC1)
278 307 (10%) (9%) 535 615 (13%) (13%)
Pfizer Ignite
15 10 47% 47% 32 14 * *
TOTAL REVENUES $ 13,283 $ 13,007 2% 3% $ 28,162 $ 31,492 (11%) (10%)
* Indicates calculation not meaningful.

2024 FINANCIAL GUIDANCE(1)
Pfizer raises full-year 2024 revenue guidance by $1 billion at the midpoint to a range of $59.5 to $62.5 billion and raises Adjusted(2) diluted EPS guidance by $0.30 at the midpoint to $2.45 to $2.65. The company’s updated guidance for revenue includes approximately $8.5 billion in anticipated revenues for Comirnaty(3) and Paxlovid, approximately $5 billion and $3.5 billion, respectively. Including the contribution from Seagen and excluding revenues from Comirnaty(3) and Paxlovid, Pfizer now expects to achieve full-year 2024 operational revenue growth of 9% to 11% compared to 2023 revenues, up from 8% to 10% provided on January 30, 2024.
The updated 2024 Adjusted(2) diluted EPS guidance takes into consideration our strong first half performance as well as our continued confidence in the underlying strength of our business.
Pfizer’s updated financial guidance(1) is presented below.
Revenues
$59.5 to $62.5 billion
(previously $58.5 to $61.5 billion)
Adjusted(2) SI&A Expenses
$13.8 to $14.8 billion
Adjusted(2) R&D Expenses
$11.0 to $12.0 billion
Effective Tax Rate on Adjusted(2) Income
Approximately 13.0%
(previously approximately 15.0%)
Adjusted(2) Diluted EPS
$2.45 to $2.65
(previously $2.15 to $2.35)

Changes in foreign exchange rates have had a minimal incremental impact since full-year 2024 guidance was updated on May 1, 2024. Please refer to Press Release Footnote (1) for additional information.

CAPITAL ALLOCATION
During the first six months of 2024, Pfizer deployed its capital in a variety of ways, which primarily include the following two categories:
▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
•$5.2 billion invested in internal research and development projects, and
•Approximately $200 million invested in business development transactions.
▪Returning capital directly to shareholders through $4.8 billion of cash dividends, or $0.84 per share of common stock.
No share repurchases were completed to date in 2024. As of July 30, 2024, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2024.
Second-quarter 2024 diluted weighted-average shares outstanding used to calculate Reported(4) and Adjusted(2) diluted EPS were 5,696 million shares.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2024 vs. Second-Quarter 2023)
Second-quarter 2024 revenues totaled $13.3 billion, an increase of $277 million, or 2%, compared to the prior-year quarter, reflecting an operational increase of $447 million, or 3%, primarily due to growth contributions from several of our acquired products, key in-line products, and recent commercial launches, which more than offset both an expected decline in Comirnaty(3) revenues globally and an unfavorable impact of foreign exchange of $170 million, or 1%. Excluding contributions from Comirnaty(3) and Paxlovid, revenues totaled $12.8 billion, an increase of $1.6 billion, or 14%, operationally compared with the prior-year quarter.
Second-quarter 2024 Comirnaty(3) revenues of $195 million declined $1.3 billion, or 87%, operationally compared with the prior-year quarter, driven largely by lower contractual deliveries and demand in international markets, reflecting the anticipated seasonality of demand for vaccinations and as certain markets, including the U.S., transition to traditional commercial market sales.
Second-quarter 2024 Paxlovid revenues of $251 million increased $112 million, or 79%, operationally compared with the prior-year quarter, driven primarily by no second quarter 2023 U.S. sales in anticipation of transition to commercial markets in the second half of 2023, as well as increases in infections and demand in certain international markets in the second quarter of 2024.

Excluding contributions from Comirnaty(3) and Paxlovid, second-quarter 2024 operational revenue growth was driven primarily by:
▪Global revenues of $845 million from legacy Seagen, which was acquired in December of 2023;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 71% operationally, driven largely by continued strong demand, primarily in the U.S. and international developed markets;
▪Eliquis globally, up 8% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of patent-based exclusivity and generic competition in certain international markets; and
▪Nurtec ODT/Vydura globally, up 44% operationally, driven primarily by strong demand in the U.S. as well as recent launches in international markets;
partially offset primarily by lower revenues for:
▪Xeljanz globally, down 34% operationally, driven primarily by decreased prescription volumes globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as lower net price in the U.S. due to unfavorable changes in channel mix and the impact of regulatory exclusivity expiry in Canada; and
▪Ibrance globally, down 8% operationally, driven primarily by lower demand due to competitive pressure globally and price decreases in certain international developed markets, partially offset by increased clinical trial supply orders in certain international developed markets versus prior year.

GAAP Reported(4) Statement of Operations Highlights
SELECTED REPORTED(4) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2024 2023 % Change 2024 2023 % Change
Total Oper. Total Oper.
Cost of Sales(4)
$ 3,300 $ 3,237 2% 5% $ 6,679 $ 8,122 (18%) (15%)
Percent of Revenues
24.8 % 24.9 % N/A N/A 23.7 % 25.8 % N/A N/A
SI&A Expenses(4)
3,717 3,497 6% 7% 7,212 6,914 4% 5%
R&D Expenses(4)
2,696 2,648 2% 2% 5,189 5,153 1% 1%
Acquired IPR&D Expenses(4)
6 33 (81%) (81%) 6 55 (88%) (88%)
Other (Income)/Deductions—net(4)
1,107 (75) * * 1,787 200 * *
Effective Tax Rate on Reported(4) Income
130.2 % (3.1 %) 4.8 % 7.5 %

* Indicates calculation not meaningful.
Second-quarter 2024 Cost of Sales(4) as a percentage of revenues was relatively flat compared with the prior-year quarter, and reflects favorable changes in sales mix, primarily driven by lower sales of Comirnaty(3), which resulted in a lower related charge for the 50% gross profit split with BioNTech and applicable royalty expenses in the quarter; offset by the amortization of the fair value step-up of inventory related to the Seagen acquisition.
Second-quarter 2024 SI&A Expenses(4) increased 7% operationally compared with the prior-year quarter, driven primarily by an increase in marketing and promotional expenses for recently launched and acquired products.
Second-quarter 2024 R&D Expenses(4) increased 2% operationally compared with the prior-year quarter, primarily due to increased spending to develop certain medicines acquired from Seagen, partially offset by lower spending primarily as a result of our cost realignment program.
The unfavorable period-over-period change in Other deductions—net(4) of $1.2 billion for the second quarter of 2024, compared with the prior-year quarter, was driven primarily by net losses on equity securities in the second quarter of 2024 versus net gains on equity securities recognized in the prior-year quarter, higher net interest expense and intangible asset impairment charges in the second quarter of 2024.
Pfizer’s effective tax rate on Reported(4) income for the second quarter of 2024 increased compared to the prior-year quarter primarily due to the non-recurrence of tax benefits related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years in the second quarter of 2023, partially offset by a favorable change in the jurisdictional mix of earnings in the second quarter of 2024.

Adjusted(2) Statement of Operations Highlights
SELECTED ADJUSTED(2) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2024 2023 % Change 2024 2023 % Change
Total Oper. Total Oper.
Adjusted(2) Cost of Sales
$ 2,768 $ 3,072 (10 %) (6 %) $ 5,804 $ 7,818 (26%) (23%)
Percent of Revenues 20.8 % 23.6 % N/A N/A 20.6 % 24.8 % N/A N/A
Adjusted(2) SI&A Expenses
3,669 3,419 7 % 8 % 7,123 6,769 5% 6%
Adjusted(2) R&D Expenses
2,671 2,627 2 % 2 % 5,147 5,118 1% 1%
Adjusted(2) Other (Income)/Deductions—net
258 (278) * * 555 (601) * *
Effective Tax Rate on Adjusted(2) Income
12.9%
6.8 % 15.1 % 11.6 %
* Indicates calculation not meaningful.

See the reconciliations of certain Reported(4) to non-GAAP Adjusted(2) financial measures and associated footnotes in the financial tables section of this press release.
RECENT NOTABLE DEVELOPMENTS (Since May 1, 2024)
Product Developments
Product/Project
Recent Development
Link
Adcetris
(brentuximab vedotin)
July 2024. Pfizer’s supplemental Biologics License Application (sBLA) for Adcetris in combination with lenalidomide and rituximab for patients with relapsed/refractory large B-cell lymphoma was accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of March 2025. If approved, this would be the eighth FDA-approved indication for Adcetris.
N/A
June 2024. Presented detailed overall survival (OS) results from the investigational Phase 3 ECHELON-3 study of Adcetris in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Detailed data from the study demonstrated the investigational Adcetris regimen reduced risk of death by 37 percent compared to chemotherapy alone, resulting in median OS of 13.8 months versus 8.5 months. The most frequently reported treatment-emergent adverse events Grade 3 or higher for the Adcetris versus placebo arms were neutropenia, thrombocytopenia and anemia.
Full Release
June 2024. Takeda and Pfizer announced positive results from the Phase 3 HD21 trial evaluating Adcetris in combination with intensive chemotherapy. The four-year analysis conducted and presented by the German Hodgkin Study Group (GHSG) at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting showed superior progression-free survival (PFS) and improved tolerability for patients with newly diagnosed Stage IIb/III/IV classical Hodgkin Lymphoma compared to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone (eBEACOPP), a current standard of care regimen predominantly used in Europe in this setting.

Product/Project
Recent Development
Link
Comirnaty(3)
(COVID-19 Vaccine, mRNA)
June 2024. Announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Pfizer and BioNTech’s Omicron JN.1-adapted monovalent COVID-19 vaccine (Comirnaty JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Subsequently, the European Commission (EC) authorized the vaccine on July 3, 2024.
Full Release
Durveqtix (fidanacogene elaparvovec)
July 2024. Announced the EC granted conditional marketing authorization for Durveqtix, a gene therapy for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74. This follows the EMA’s CHMP positive opinion adopted in May. Durveqtix has shown the potential to offer long-term bleed protection in a one-time dose, reducing or eliminating bleeds for appropriate patients with hemophilia B. The EC approval follows recent regulatory approvals by the FDA and Health Canada, where it is marketed as Beqvez.
Full Release
Elrexfio
(elranatamab-bcmm)
June 2024. Presented detailed OS results from the Phase 2 MagnetisMM-3 study of Elrexfio in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM) who had not received prior B-cell maturation antigen (BCMA)-directed therapy (i.e., BCMA-naïve; Cohort A; n=123) at EHA (Free EHA Whitepaper) 2024. With a median follow-up of 28.4 months (estimated by the reverse-Kaplan-Meier method), the study demonstrated a median OS of 24.6 months, with median PFS of 17.2 months for the full intent-to-treat cohort. The safety and tolerability of Elrexfio in MagnetisMM-3 were consistent with what have been previously observed.
Full Release
Lorbrena
(lorlatinib)
May 2024. Presented longer-term follow-up results from the Phase 3 CROWN trial evaluating Lorbrena versus Xalkori (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) at the ASCO (Free ASCO Whitepaper) Annual Meeting that were simultaneously published in the Journal of Clinical Oncology. Updated results showed an unprecedented 60% of patients remain alive without disease progression after five years, along with continued 81% reduction in risk of progression or death and 94% reduction in progression of brain metastases compared to Xalkori. The safety profiles of Lorbrena and Xalkori in the five-year follow-up were consistent with previous findings, with no new safety signals reported for Lorbrena.
Full Release

Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
Product/Project Recent Development Link
danuglipron
July 2024. Announced advancement of development of once-daily formulation of oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron. Based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected its preferred once-daily modified release formulation for danuglipron. With these results, and following a thorough analysis of previous Phase 2b data and trial design, Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
Product/Project Recent Development Link
fordadistrogene movaparvovec
June 2024. Announced CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo. Key secondary endpoints also did not show a significant difference between participants treated with fordadistrogene movaparvovec and placebo.
Full Release
giroctocogene fitelparvovec
July 2024. Announced positive topline results from the Phase 3 AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A. The AFFINE study achieved its primary objective of non-inferiority, as well as superiority, of total annualized bleeding rate (ABR) from Week 12 through at least 15 months of follow up post-infusion compared with routine Factor VIII (FVIII) replacement prophylaxis treatment. Key secondary endpoints as defined by the trial protocol were met and also demonstrated superiority compared to prophylaxis. Giroctocogene fitelparvovec was generally well tolerated in the study. Pfizer will discuss these data with regulatory authorities in the coming months.
Full Release
Pandemic Influenza Vaccine Candidate
May 2024. Announced that preliminary results from a subset of patients randomized in a Phase 1 study (NCT06179446) evaluating the safety, tolerability, and immunogenicity of multiple doses of a nucleoside-modified mRNA (modRNA) based pandemic influenza vaccine candidate illustrated notable increases in antibody responses against the avian strain [H5, Clade 2.3.4.4b] of H5 influenza virus. Pfizer continues to monitor all developments regarding the circulation and outbreaks of the A/H5N1 virus. If a vaccine is needed in an emergency pandemic situation, Pfizer anticipates that the modRNA vaccine platform could be leveraged to rapidly provide a vaccine candidate targeting the specific pandemic influenza strain.
Full Release

Corporate Developments
Topic Recent Development Link
Board Election
July 2024. Announced Cyrus Taraporevala was elected to Pfizer’s Board of Directors. Mr. Taraporevala was also appointed to and will join the Audit Committee and Compensation Committee of Pfizer’s Board.

Executive Leadership
July 2024. Announced the launch of a process to identify a successor for Dr. Mikael Dolsten, Chief Scientific Officer and President, Pfizer R&D, who will depart the company after a 15+ year stellar career. Dr. Dolsten will assist in the external search for a new Chief Scientific Officer and continue to serve in his current position until his successor is in place and any necessary transition is complete.

May 2024. Announced Andrew Baum, M.D., would join the company as Chief Strategy and Innovation Officer, Executive Vice President, effective June 3, 2024, and will become a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Dr. Albert Bourla. In his role, Dr. Baum will be responsible for Pfizer’s long-term corporate strategic plan, and Pfizer’s portfolio analysis and prioritization functions, business development activities, strengthening of partnerships with the biotech ecosystem, and the commercial evaluation of the company’s research pipeline.

Topic Recent Development Link
Manufacturing Optimization Program
May 2024. Announced the launch of the first phase of a multi-year, multi-phase cost reduction program (the "Manufacturing Optimization Program" or "the program") to reduce our cost of goods sold. The program is expected to include operational efficiencies, network structure changes, and product portfolio enhancements. The first phase of the program is focused on operational efficiencies and is expected to deliver savings of approximately $1.5 billion by the end of 2027, some of which is expected to begin being realized in 2025. The one-time costs to achieve the savings associated with the first phase of the program are expected to be approximately $1.7 billion and primarily include severance and implementation costs. These costs will be recorded primarily in 2024, with cash outlays expected primarily in 2025 and 2026.

For additional details, see the attached financial schedules, product revenue tables and disclosure notice.
(1)Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
Financial guidance for full-year 2024 reflects the following:
▪Does not assume the completion of any business development transactions not completed as of June 30, 2024.
▪An anticipated immaterial impact in fiscal-year 2024 of recent and expected generic and biosimilar competition for certain products that have recently lost patent or regulatory protection or that are anticipated to lose patent or regulatory protection.
▪Exchange rates assumed are a blend of actual rates in effect through second-quarter 2024 and mid-July 2024 rates for the remainder of the year. Financial guidance reflects the anticipated unfavorable impact of approximately $0.6 billion on revenues and the anticipated unfavorable impact of approximately $0.04 on Adjusted(2) diluted EPS as a result of changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2023.
▪Guidance for Adjusted(2) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.7 billion shares, and assumes no share repurchases in 2024.
▪Guidance assumes the seasonal cadence of certain products in our portfolio, and that Paxlovid results trend with infection rates.
(2)Adjusted income and Adjusted diluted EPS are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and U.S. GAAP diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the second quarter and the first six months of 2024 and 2023. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS(4). See the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2023 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income section of this press release for a definition of each component of Adjusted income as well as other relevant information.
(3)As used in this document, "Comirnaty" refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine; Comirnaty (COVID-19 Vaccine, mRNA) original monovalent formula; the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5); the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula); Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula; Comirnaty Original/Omicron BA.1; Comirnaty Original/Omicron BA.4/BA.5; Comirnaty Omicron XBB.1.5; and Comirnaty JN.1. "Comirnaty" includes product revenues and alliance revenues related to sales of the above-mentioned vaccines.
(4)Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income and its components are defined as net income attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(5)Second-quarter 2024 Reported(4) diluted EPS was unfavorably impacted by $0.18 resulting from a $1.3 billion one-time restructuring charge related to the Manufacturing Optimization Program.
(6)The targeted $4 billion in net cost savings is calculated versus the midpoint of Pfizer’s 2023 SI&A and R&D expense guidance provided on August 1, 2023. As an additional reference, see the ‘2024 Financial Guidance’ section of Pfizer’s fourth-quarter 2023 earnings release.
(7)References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results.
(8)Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s second quarter and first six months for U.S. subsidiaries reflects the three and six months ended on June 30, 2024 and July 2, 2023, while Pfizer’s second quarter and first six months for subsidiaries operating outside the U.S. reflects the three and six months ended on May 26, 2024 and May 28, 2023.