Vertex Reports Third Quarter 2024 Financial Results
Vertex Pharmaceuticals reported strong Q3 2024 results with product revenue of $2.77 billion, up 12% year-over-year. The company raised its full-year 2024 product revenue guidance to $10.8-10.9 billion. Q3 performance was driven by TRIKAFTA/KAFTRIO's continued strong performance, with U.S. revenue up 10% to $1.71 billion and international revenue up 14% to $1.06 billion. The company is preparing for two potential near-term launches: vanzacaftor triple in CF and suzetrigine for acute pain. Three additional programs advanced to Phase 3: suzetrigine in DPN, povetacicept in IgAN, and VX-880 in T1D.
Vertex Pharmaceuticals ha riportato risultati positivi per il terzo trimestre del 2024, con un fatturato da prodotto di 2,77 miliardi di dollari, in aumento del 12% rispetto all’anno precedente. L’azienda ha alzato le stime di fatturato per l'intero anno 2024 a 10,8-10,9 miliardi di dollari. Le performance del terzo trimestre sono state trainate dal continuo successo di TRIKAFTA/KAFTRIO, con un fatturato negli Stati Uniti aumentato del 10% a 1,71 miliardi di dollari e un fatturato internazionale aumentato del 14% a 1,06 miliardi di dollari. L’azienda si sta preparando per due lanci potenziali a breve termine: vanzacaftor triplo per la fibrosi cistica e suzetrigine per il dolore acuto. Tre ulteriori programmi sono avanzati alla Fase 3: suzetrigine per la neuropatia diabetica periferica, povetacicept per l’IgAN e VX-880 per il diabete di tipo 1.
Vertex Pharmaceuticals reportó resultados sólidos para el tercer trimestre de 2024, con ingresos por productos de 2.77 mil millones de dólares, un aumento del 12% en comparación con el año anterior. La compañía elevó su guía de ingresos para productos del año completo 2024 a 10.8-10.9 mil millones de dólares. El desempeño del tercer trimestre fue impulsado por el continuo rendimiento fuerte de TRIKAFTA/KAFTRIO, con ingresos en EE. UU. aumentando un 10% a 1.71 mil millones de dólares e ingresos internacionales creciendo un 14% a 1.06 mil millones de dólares. La compañía se está preparando para dos lanzamientos potenciales a corto plazo: vanzacaftor triple para la fibrosis quística y suzetrigina para el dolor agudo. Tres programas adicionales avanzaron a la Fase 3: suzetrigina en neuropatía diabética periférica, povetacicept en IgAN, y VX-880 en diabetes tipo 1.
Vertex Pharmaceuticals는 2024년 3분기에 27억 7천만 달러의 제품 매출을 기록하며 전년 대비 12% 증가한 강력한 실적을 보고했습니다. 이 회사는 2024년 전체 연도 제품 매출 가이던스를 108억-109억 달러로 상향 조정했습니다. 3분기의 실적은 TRIKAFTA/KAFTRIO의 지속적인 강력한 실적에 의해 주도되었으며, 미국 매출은 10% 증가하여 17억 1천만 달러에 도달했고, 국제 매출은 14% 증가하여 10억 6천만 달러에 달했습니다. 이 회사는 단기적으로 발생할 수 있는 두 가지 출시를 준비하고 있습니다: 섬유낭종을 위한 vanzacaftor triple 및 급성 통증을 위한 suzetrigine. 세 가지 추가 프로그램이 3상으로 진입했습니다: 당뇨병성 말초신경병증에 대한 suzetrigine, IgAN에 대한 povetacicept, 및 1형 당뇨병에 대한 VX-880.
Vertex Pharmaceuticals a annoncé de bons résultats pour le troisième trimestre 2024, avec des revenus de produits atteignant 2,77 milliards de dollars, soit une augmentation de 12 % par rapport à l'année précédente. La société a relevé ses prévisions de revenus de produits pour l'ensemble de l'année 2024 à 10,8-10,9 milliards de dollars. Les performances du troisième trimestre ont été soutenues par les ventes continues solides de TRIKAFTA/KAFTRIO, avec des revenus aux États-Unis en hausse de 10 % à 1,71 milliard de dollars et des revenus internationaux en hausse de 14 % à 1,06 milliard de dollars. L’entreprise se prépare à deux lancements potentiels à court terme : le vanzacaftor triple pour la fibrose kystique et le suzetrigine pour la douleur aiguë. Trois programmes supplémentaires sont passés en phase 3 : suzetrigine pour la neuropathie diabétique périphérique, povetacicept pour l'IgAN, et VX-880 pour le diabète de type 1.
Vertex Pharmaceuticals berichtete über starke Ergebnisse für das dritte Quartal 2024 mit Produktumsätzen von 2,77 Milliarden Dollar, was einem Anstieg von 12 % im Vergleich zum Vorjahr entspricht. Das Unternehmen hob seine Umsatzprognose für das Gesamtjahr 2024 auf 10,8-10,9 Milliarden Dollar an. Die Leistungen im dritten Quartal wurden durch die anhaltend starke Performance von TRIKAFTA/KAFTRIO angetrieben, wobei die Umsätze in den USA um 10 % auf 1,71 Milliarden Dollar und die internationalen Umsätze um 14 % auf 1,06 Milliarden Dollar stiegen. Das Unternehmen bereitet sich auf zwei potenzielle kurzfristige Markteinführungen vor: vanzacaftor triple für die zystische Fibrose und suzetrigine für akute Schmerzen. Drei weitere Programme haben die Phase 3 erreicht: suzetrigine bei DPN, povetacicept bei IgAN und VX-880 bei Typ-1-Diabetes.
- Product revenue grew 12% YoY to $2.77 billion in Q3 2024
- Raised full-year revenue guidance to $10.8-10.9 billion
- U.S. revenue increased 10% to $1.71 billion
- International revenue grew 14% to $1.06 billion
- Strong cash position with $11.2 billion in cash and marketable securities
- Combined R&D and SG&A expenses increased to $1.2 billion from $1.1 billion YoY
- Cash position decreased from $13.7 billion to $11.2 billion since December 2023
Insights
The Q3 results show impressive performance with
The balance sheet remains robust with
The pipeline progress is particularly noteworthy with three programs advancing to Phase 3, suggesting strong potential for revenue diversification beyond CF franchise. Near-term catalysts include potential launches of vanzacaftor triple and suzetrigine, which could materially impact revenue trajectory in 2025.
The advancement of multiple programs to Phase 3 represents significant clinical progress. Key developments include suzetrigine for diabetic peripheral neuropathy, povetacicept for IgA nephropathy and VX-880 for Type 1 diabetes. The VX-880 program's progression to pivotal development following regulatory agency meetings is particularly promising.
The CASGEVY launch is gaining traction with 45 authorized treatment centers activated globally. Early commercialization success and expanding regulatory approvals in multiple regions demonstrate strong execution in cell therapy. The pipeline diversity across CF, pain, kidney diseases and diabetes positions Vertex well for sustainable long-term growth beyond its core CF franchise.
— Product revenue of
— Raising full-year product revenue guidance to
— Preparing for two potential near-term launches: vanzacaftor triple in CF and suzetrigine (VX-548) for moderate-to-severe acute pain —
— Pipeline progress continuing with three additional programs advancing to Phase 3: suzetrigine in DPN, povetacicept in IgAN and VX-880 in T1D —
“The third quarter marked another period of strong progress, with continued revenue growth and outstanding execution across the business, and we are again increasing our full-year product revenue guidance,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “Launch preparedness is well underway as we look forward to the potential approvals of the vanzacaftor triple for cystic fibrosis and suzetrigine, a new class of medicine for moderate-to-severe acute pain. With a broad and deep pipeline and three additional programs advancing to Phase 3 development in the last quarter alone, Vertex is well positioned for continued long-term growth.”
Third Quarter 2024 Results
Product revenue increased
Combined GAAP and Non-GAAP R&D and SG&A expenses were
Acquired IPR&D (AIPR&D) expenses were
GAAP effective tax rate was
Non-GAAP effective tax rate was
GAAP and Non-GAAP net income were
Cash, cash equivalents and total marketable securities as of September 30, 2024 were
Full-Year 2024 Financial Guidance
Vertex today raised its full-year 2024 product revenue guidance from
Vertex’s updated financial guidance is summarized below:
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Current FY 2024 |
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Previous FY 2024 |
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Total product revenue |
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Combined GAAP R&D and SG&A expenses (2) |
Unchanged |
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Combined Non-GAAP R&D and SG&A expenses (2) |
Unchanged |
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AIPR&D expenses |
Unchanged |
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Non-GAAP effective tax rate** |
~ |
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~ |
*Includes Alpine AIPR&D expense of |
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**Vertex’s full-year Non-GAAP tax rate is impacted by the Alpine AIPR&D expense, which is non-deductible for tax. |
Key Business Highlights
Marketed Products and Potential Near-Term Launch Opportunities
Cystic Fibrosis (CF) Portfolio
Vertex anticipates the number of CF patients taking its medicines will continue to grow through new approvals and reimbursement for the treatment of younger patients. Recent and anticipated progress includes:
- As of the third quarter of 2024, KAFTRIO is now reimbursed in all 27 countries of the European Union.
-
The
U.S. Food and Drug Administration (FDA) has assigned the once-daily vanzacaftor triple in people with CF 6 years and older a Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025. The vanzacaftor triple was granted Priority Review by the FDA. -
Vertex has completed regulatory submissions for the vanzacaftor triple in the European Union (EU), the
United Kingdom (U.K. ),Canada ,Australia ,New Zealand andSwitzerland , and reviews are underway. - In July, Health Canada granted approval to TRIKAFTA for an additional 152 rare mutations in the CFTR gene.
- Vertex has submitted regulatory applications to the FDA and the European Medicines Agency (EMA) for TRIKAFTA/KAFTRIO for the treatment of people with CF and rare responsive mutations.
CASGEVY for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)
CASGEVY® is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT that has been shown to reduce or eliminate vaso-occlusive crises (VOCs) for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved in the
-
Vertex received regulatory approvals for CASGEVY for the treatment of patients 12 years of age and older with SCD or TDT in
Switzerland andCanada . - As of mid-October, Vertex has activated 45 authorized treatment centers (ATCs) globally and increasing numbers of patients across all regions have initiated cell collection.
- In the third quarter of 2024, Vertex’s product revenue included revenue from the first patient infused with CASGEVY.
- Vertex announced a reimbursement agreement with NHS England for eligible patients with TDT to access CASGEVY. Vertex has also entered into commercial discussions with NHS England to secure access to CASGEVY for eligible patients with SCD.
- The Italian Medicines Agency approved Vertex’s request for the implementation of an early access program (EAP), for the use of CASGEVY for the treatment of TDT and SCD.
Suzetrigine (VX-548) for the treatment of moderate-to-severe acute pain
Vertex has discovered and continues to advance multiple selective small molecule inhibitors of NaV1.8, with the goal of creating a new class of pain medicines that has the potential to provide effective pain relief without the limitations of opioids and other currently available medicines.
- The FDA has assigned a PDUFA target action date of January 30, 2025, for suzetrigine for the treatment of moderate-to-severe acute pain. Suzetrigine was granted Priority Review by the FDA.
Select Clinical-Stage R&D Pipeline
Cystic Fibrosis
Vertex continues to pursue next-in-class, small molecule, oral CFTR modulators for the ~
-
Vanzacaftor/tezacaftor/deutivacaftor, the once-daily, next-in-class triple oral small molecule combination, in cystic fibrosis
- Vertex is enrolling and dosing a study in children with cystic fibrosis ages 2 to 5 years who have at least one F508del mutation or a mutation responsive to triple combination CFTR modulators.
- Consistent with its commitment to serial innovation and bringing as many patients as possible to normal levels of CFTR function, Vertex continues to advance new oral small molecule combination therapies through preclinical and clinical development. The most advanced next-wave CFTR modulators have completed, or are in the process of completing, Phase 1 clinical trials.
-
VX-522, nebulized mRNA therapy
- Vertex completed the single ascending dose (SAD) portion of the Phase 1/2 study of VX-522 in people with CF in late 2023, and the multiple ascending dose (MAD) portion of the study is ongoing. Vertex expects to complete the trial and share data in the first half of 2025.
Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
- Vertex has completed enrollment in two global Phase 3 studies of CASGEVY in children 5 to 11 years of age with SCD or TDT and the trials are ongoing.
- Vertex continues to work on preclinical assets for gentler conditioning for CASGEVY, which could broaden the eligible patient population.
Acute Pain
- Vertex has initiated a Phase 2 study for an oral formulation of VX-993, a next-generation selective NaV1.8 pain signal inhibitor, for the treatment of moderate-to-severe acute pain following bunionectomy surgery.
- Vertex continues to enroll and dose the Phase 1 trial for an intravenous formulation of VX-993.
- The FDA has granted Fast Track Designation to VX-993 in moderate-to-severe acute pain in both its oral and intravenous formulations.
Peripheral Neuropathic Pain (PNP)
-
Vertex has initiated the Phase 3 pivotal program of suzetrigine in patients with painful diabetic peripheral neuropathy (DPN), a type of PNP that accounts for approximately
20% of patients suffering from PNP. The FDA has granted suzetrigine Breakthrough Therapy Designation in DPN. -
Vertex has completed the Phase 2 study of suzetrigine in painful lumbosacral radiculopathy (LSR), a condition representing more than
40% of patients suffering from PNP. Vertex continues to expect to share results from this study by the end of the year. - Vertex has also initiated a Phase 2 study for the oral formulation of VX-993 for the treatment of DPN.
Consistent with its commitment to serial innovation and leadership in pain, Vertex continues to develop additional NaV1.8 inhibitors and NaV1.7 inhibitors, for stand-alone use or in combination, for the treatment of acute and peripheral neuropathic pain.
APOL1-Mediated Kidney Disease (AMKD)
Vertex has discovered and advanced multiple oral, small molecule inhibitors of APOL1 function, pioneering a new class of medicines that targets the underlying genetic driver of this kidney disease.
- Vertex continues to enroll and dose patients with AMKD in the Phase 3 portion of the global Phase 2/3 pivotal clinical trial of inaxaplin, in which a 45 mg once-daily dose of inaxaplin is compared to placebo, on top of standard of care.
IgA Nephropathy (IgAN) and Other B Cell-Mediated Diseases
Vertex is developing povetacicept, a dual inhibitor of the BAFF and APRIL pathways, as a potentially best-in-class approach to treat immunoglobulin A (IgA) nephropathy. Vertex is also studying povetacicept in other serious B cell-mediated diseases, including autoimmune kidney diseases, such as primary membranous nephropathy, and autoimmune cytopenias.
-
Vertex has initiated the RAINIER study, the Phase 3 clinical trial of povetacicept in IgA nephropathy.
-
RAINIER is a global pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating the change from baseline in urine protein creatinine ratio (UPCR) for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for accelerated approval in the
U.S. Final analysis will occur at two years of treatment, with a primary endpoint of total estimated glomerular filtration rate (eGFR) slope through Week 104.
-
RAINIER is a global pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating the change from baseline in urine protein creatinine ratio (UPCR) for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for accelerated approval in the
-
Vertex presented updated data on 54 patients with IgAN from the RUBY-3 Phase 1b/2 basket study of povetacicept at the American Society of Nephrology (ASN) Annual Meeting. Treatment with povetacicept 80 mg dosed subcutaneously every four weeks demonstrated a clinically meaningful decrease in proteinuria, with a mean
66% reduction from baseline in UPCR (n=8) at 48 weeks associated with stable renal function over 48 weeks as assessed by eGFR. By 48 weeks,63% (5 out of 8) of study participants achieved clinical remission, defined as UPCR < 0.5 g/g, negative hematuria, and stable renal function (≤25% reduction in eGFR from baseline). Treatment with povetacicept 240 mg dosed subcutaneously every four weeks was associated with similar improvements in proteinuria, and stable renal function, and both doses have been well tolerated in patients with IgAN. -
Vertex also presented emerging data on povetacicept from RUBY-3 in patients with primary membranous nephropathy (pMN) at ASN. Treatment with povetacicept 80 mg dosed subcutaneously every four weeks demonstrated a mean
62% reduction from baseline in UPCR (n=3) at 24 weeks, associated with stable renal function. By week 24, 2/3 of patients (67% ) had achieved partial clinical remission, defined as UPCR < 3.5 g/g and ≥50% reduction in UPCR from baseline. Povetacicept was also well-tolerated in these patients with pMN. - Vertex is studying additional renal diseases in the RUBY-3 basket study and hematologic conditions in the RUBY-4 basket study, both of which are ongoing.
Type 1 Diabetes (T1D)
Vertex is evaluating stem cell-derived, fully differentiated islet cell therapies for patients suffering from T1D, with the goal of developing a potential one-time functional cure for this disease.
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VX-880, fully differentiated islet cells with standard immunosuppression:
-
Following successful end of Phase 2 meetings with the FDA, EMA and the
U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Vertex has reached agreement to advance VX-880 into pivotal development with the conversion of the ongoing Phase 1/2 study to a Phase 1/2/3 study. - The Phase 1/2/3 study will include a total of 50 patients infused with a single, target dose of VX-880. The primary endpoint is the proportion of patients with insulin independence and absence of severe hypoglycemic episodes (SHEs).
-
Following successful end of Phase 2 meetings with the FDA, EMA and the
-
VX-264, fully differentiated islet cells encapsulated in an immunoprotective device:
- The clinical trial for VX-264, which encapsulates the same VX-880 islet cells in a novel device so that treatment with immunosuppressants is not required, is a global, multi-part, Phase 1/2 study.
- Vertex has completed Part A of the study. As with the VX-880 study, patients in Part A receive a low dose with a stagger period between dosing.
- Part B of the Phase 1/2 study is enrolling and dosing patients. In Part B, patients receive the full target dose with a stagger period between patients, and in Part C, patients will receive the full target dose with no stagger.
- Vertex expects to share initial data from this study in 2025.
-
Hypoimmune, edited fully differentiated islet cells:
- Vertex’s hypoimmune cell program involves editing the same stem cell-derived, fully differentiated VX-880 islet cells to protect the cells from the immune system, hence avoiding the need for immunosuppression. This research-stage program continues to make progress.
Myotonic Dystrophy Type 1 (DM1)
Vertex is evaluating multiple approaches that target the underlying cause of DM1, the most prevalent muscular dystrophy in adults, with ~110,000 people living with the disease in the
- Vertex recently completed the single ascending dose (SAD) portion of the global Phase 1/2 clinical trial for VX-670 in people with DM1.
- Vertex has initiated the MAD portion of the Phase 1/2 study, in which both the safety and efficacy of VX-670 will be evaluated.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Vertex is developing small molecule correctors that restore function to the variant polycystin 1 (PC1) protein, with the goal of addressing the underlying cause of ADPKD, the most common genetic kidney disease, affecting approximately 250,000 people in the
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Vertex continues to enroll and dose its Phase 1 clinical trial in healthy volunteers for VX-407, a first-in-class small molecule corrector that targets the underlying cause of ADPKD in patients with a subset of variants in the PKD1 gene, which encodes the PC1 protein, estimated to be ~25,000 (or ~
10% ) of the overall patient population.
Non-GAAP Financial Measures
In this press release, Vertex's financial results and financial guidance are provided in accordance with accounting principles generally accepted in
The company provides guidance regarding combined R&D and SG&A expenses and effective tax rate on a non-GAAP basis. The guidance regarding Acquired IPR&D expenses does not include estimates associated with any potential future business development transactions, including collaborations, asset acquisitions and/or licensing of third-party intellectual property rights. The company does not provide guidance regarding its GAAP effective tax rate because it is unable to forecast with reasonable certainty the impact of excess tax benefits related to stock-based compensation and the possibility of certain discrete items, which could be material.
Vertex Pharmaceuticals Incorporated Consolidated Statements of Income (in millions, except per share amounts)(unaudited) |
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|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
Product revenues, net |
$ |
2,771.9 |
|
|
$ |
2,483.5 |
|
|
$ |
8,108.1 |
|
|
$ |
7,351.5 |
|
Costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of sales |
|
392.6 |
|
|
|
318.7 |
|
|
|
1,107.1 |
|
|
|
894.2 |
|
Research and development expenses |
|
875.9 |
|
|
|
810.0 |
|
|
|
2,631.6 |
|
|
|
2,338.3 |
|
Acquired in-process research and development expenses |
|
15.0 |
|
|
|
51.7 |
|
|
|
4,540.9 |
|
|
|
509.3 |
|
Selling, general and administrative expenses |
|
371.8 |
|
|
|
263.8 |
|
|
|
1,086.7 |
|
|
|
767.5 |
|
Change in fair value of contingent consideration |
|
0.3 |
|
|
|
1.2 |
|
|
|
0.7 |
|
|
|
(1.3 |
) |
Total costs and expenses |
|
1,655.6 |
|
|
|
1,445.4 |
|
|
|
9,367.0 |
|
|
|
4,508.0 |
|
Income (loss) from operations |
|
1,116.3 |
|
|
|
1,038.1 |
|
|
|
(1,258.9 |
) |
|
|
2,843.5 |
|
Interest income |
|
132.2 |
|
|
|
167.9 |
|
|
|
469.9 |
|
|
|
435.2 |
|
Interest expense |
|
(7.5 |
) |
|
|
(10.9 |
) |
|
|
(27.8 |
) |
|
|
(33.5 |
) |
Other expense, net |
|
(16.9 |
) |
|
|
(15.9 |
) |
|
|
(71.2 |
) |
|
|
(13.0 |
) |
Income (loss) before provision for income taxes |
|
1,224.1 |
|
|
|
1,179.2 |
|
|
|
(888.0 |
) |
|
|
3,232.2 |
|
Provision for income taxes |
|
178.7 |
|
|
|
143.9 |
|
|
|
560.6 |
|
|
|
581.4 |
|
Net income (loss) |
$ |
1,045.4 |
|
|
$ |
1,035.3 |
|
|
$ |
(1,448.6 |
) |
|
$ |
2,650.8 |
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per common share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
4.05 |
|
|
$ |
4.01 |
|
|
$ |
(5.61 |
) |
|
$ |
10.29 |
|
Diluted |
$ |
4.01 |
|
|
$ |
3.97 |
|
|
$ |
(5.61 |
) |
|
$ |
10.18 |
|
Shares used in per share calculations: |
|
|
|
|
|
|
|
||||||||
Basic |
|
258.0 |
|
|
|
258.0 |
|
|
|
258.1 |
|
|
|
257.7 |
|
Diluted |
|
261.0 |
|
|
|
260.6 |
|
|
|
258.1 |
|
|
|
260.4 |
|
Vertex Pharmaceuticals Incorporated Product Revenues (in millions)(unaudited) |
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Three Months Ended
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Nine Months Ended
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||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||
TRIKAFTA/KAFTRIO |
$ |
2,585.0 |
|
$ |
2,274.3 |
|
$ |
7,517.8 |
|
$ |
6,611.4 |
Other product revenues |
|
186.9 |
|
|
209.2 |
|
|
590.3 |
|
|
740.1 |
Product revenues, net |
$ |
2,771.9 |
|
$ |
2,483.5 |
|
$ |
8,108.1 |
|
$ |
7,351.5 |
Vertex Pharmaceuticals Incorporated Reconciliation of GAAP to Non-GAAP Financial Information (in millions, except percentages)(unaudited) |
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Three Months Ended
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Nine Months Ended
|
||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
GAAP cost of sales |
$ |
392.6 |
|
|
$ |
318.7 |
|
|
$ |
1,107.1 |
|
|
$ |
894.2 |
|
Stock-based compensation expense |
|
(1.9 |
) |
|
|
(1.7 |
) |
|
|
(5.5 |
) |
|
|
(5.4 |
) |
Intangible asset amortization expense |
|
(5.0 |
) |
|
|
— |
|
|
|
(15.1 |
) |
|
|
— |
|
Non-GAAP cost of sales |
$ |
385.7 |
|
|
$ |
317.0 |
|
|
$ |
1,086.5 |
|
|
$ |
888.8 |
|
|
|
|
|
|
|
|
|
||||||||
GAAP research and development expenses |
$ |
875.9 |
|
|
$ |
810.0 |
|
|
$ |
2,631.6 |
|
|
$ |
2,338.3 |
|
Stock-based compensation expense |
|
(111.0 |
) |
|
|
(81.1 |
) |
|
|
(327.5 |
) |
|
|
(231.9 |
) |
Intangible asset amortization expense |
|
(0.9 |
) |
|
|
— |
|
|
|
(0.9 |
) |
|
|
— |
|
Acquisition-related costs (3) |
|
— |
|
|
|
(2.9 |
) |
|
|
(172.3 |
) |
|
|
(8.5 |
) |
Non-GAAP research and development expenses |
$ |
764.0 |
|
|
$ |
726.0 |
|
|
$ |
2,130.9 |
|
|
$ |
2,097.9 |
|
|
|
|
|
|
|
|
|
||||||||
GAAP selling, general and administrative expenses |
$ |
371.8 |
|
|
$ |
263.8 |
|
|
$ |
1,086.7 |
|
|
$ |
767.5 |
|
Stock-based compensation expense |
|
(71.7 |
) |
|
|
(48.1 |
) |
|
|
(197.7 |
) |
|
|
(135.3 |
) |
Acquisition-related costs (3) |
|
— |
|
|
|
— |
|
|
|
(36.5 |
) |
|
|
— |
|
Non-GAAP selling, general and administrative expenses |
$ |
300.1 |
|
|
$ |
215.7 |
|
|
$ |
852.5 |
|
|
$ |
632.2 |
|
|
|
|
|
|
|
|
|
||||||||
Combined non-GAAP R&D and SG&A expenses |
$ |
1,064.1 |
|
|
$ |
941.7 |
|
|
$ |
2,983.4 |
|
|
$ |
2,730.1 |
|
|
|
|
|
|
|
|
|
||||||||
GAAP other expense, net |
$ |
(16.9 |
) |
|
$ |
(15.9 |
) |
|
$ |
(71.2 |
) |
|
$ |
(13.0 |
) |
Decrease in fair value of strategic investments |
|
10.8 |
|
|
|
6.2 |
|
|
|
50.5 |
|
|
|
0.2 |
|
Non-GAAP other expense, net |
$ |
(6.1 |
) |
|
$ |
(9.7 |
) |
|
$ |
(20.7 |
) |
|
$ |
(12.8 |
) |
|
|
|
|
|
|
|
|
||||||||
GAAP provision for income taxes |
$ |
178.7 |
|
|
$ |
143.9 |
|
|
$ |
560.6 |
|
|
$ |
581.4 |
|
Tax adjustments (1) |
|
104.0 |
|
|
|
112.9 |
|
|
|
283.8 |
|
|
|
159.2 |
|
Non-GAAP provision for income taxes |
$ |
282.7 |
|
|
$ |
256.8 |
|
|
$ |
844.4 |
|
|
$ |
740.6 |
|
GAAP effective tax rate |
14.6 |
% |
|
12.2 |
% |
|
(63.1 |
)% |
|
18.0 |
% |
||||
Non-GAAP effective tax rate |
19.8 |
% |
|
19.4 |
% |
|
(1,038.6 |
)% |
|
20.5 |
% |
Vertex Pharmaceuticals Incorporated Reconciliation of GAAP to Non-GAAP Financial Information (continued) (in millions, except per share amounts)(unaudited) |
|||||||||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
GAAP operating income (loss) |
$ |
1,116.3 |
|
|
$ |
1,038.1 |
|
|
$ |
(1,258.9 |
) |
|
$ |
2,843.5 |
|
Stock-based compensation expense |
|
184.6 |
|
|
|
130.9 |
|
|
|
530.7 |
|
|
|
372.6 |
|
Intangible asset amortization expense |
|
5.9 |
|
|
|
— |
|
|
|
16.0 |
|
|
|
— |
|
Increase (decrease) in fair value of contingent consideration |
|
0.3 |
|
|
|
1.2 |
|
|
|
0.7 |
|
|
|
(1.3 |
) |
Acquisition-related costs (3) |
|
— |
|
|
|
2.9 |
|
|
|
208.8 |
|
|
|
8.5 |
|
Non-GAAP operating income (loss) |
$ |
1,307.1 |
|
|
$ |
1,173.1 |
|
|
$ |
(502.7 |
) |
|
$ |
3,223.3 |
|
|
|
|
|
|
|
|
|
||||||||
GAAP net income (loss) |
$ |
1,045.4 |
|
|
$ |
1,035.3 |
|
|
$ |
(1,448.6 |
) |
|
$ |
2,650.8 |
|
|
|
|
|
|
|
|
|
||||||||
Stock-based compensation expense |
|
184.6 |
|
|
|
130.9 |
|
|
|
530.7 |
|
|
|
372.6 |
|
Intangible asset amortization expense |
|
5.9 |
|
|
|
— |
|
|
|
16.0 |
|
|
|
— |
|
Decrease in fair value of strategic investments |
|
10.8 |
|
|
|
6.2 |
|
|
|
50.5 |
|
|
|
0.2 |
|
Increase (decrease) in fair value of contingent consideration |
|
0.3 |
|
|
|
1.2 |
|
|
|
0.7 |
|
|
|
(1.3 |
) |
Acquisition-related costs (3) |
|
— |
|
|
|
2.9 |
|
|
|
208.8 |
|
|
|
8.5 |
|
Total non-GAAP adjustments to pre-tax income (loss) |
|
201.6 |
|
|
|
141.2 |
|
|
|
806.7 |
|
|
|
380.0 |
|
Tax adjustments (1) |
|
(104.0 |
) |
|
|
(112.9 |
) |
|
|
(283.8 |
) |
|
|
(159.2 |
) |
Non-GAAP net income (loss) |
$ |
1,143.0 |
|
|
$ |
1,063.6 |
|
|
$ |
(925.7 |
) |
|
$ |
2,871.6 |
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per diluted common share: |
|
|
|
|
|
|
|
||||||||
GAAP |
$ |
4.01 |
|
|
$ |
3.97 |
|
|
$ |
(5.61 |
) |
|
$ |
10.18 |
|
Non-GAAP |
$ |
4.38 |
|
|
$ |
4.08 |
|
|
$ |
(3.59 |
) |
|
$ |
11.03 |
|
Shares used in diluted per share calculations: |
|
|
|
|
|
|
|
||||||||
GAAP and Non-GAAP |
|
261.0 |
|
|
|
260.6 |
|
|
|
258.1 |
|
|
|
260.4 |
|
Notes
1: In the three and nine months ended September 30, 2024 and 2023, “Tax adjustments” included the estimated income taxes related to non-GAAP adjustments to the company's pre-tax income (loss), discrete benefits related to prior tax years resulting from R&D tax credit studies that were completed in the third quarter of each year and excess tax benefits related to stock-based compensation.
2: The difference between the company’s full-year 2024 combined GAAP R&D and SG&A expenses and combined non-GAAP R&D and SG&A expenses guidance relates primarily to
3: In the nine months ended September 30, 2024, “Acquisition-related costs” were primarily related to compensation expense associated with cash-settled unvested Alpine equity awards.
Vertex Pharmaceuticals Incorporated Condensed Consolidated Balance Sheets (in millions)(unaudited) |
|||||
|
September 30, 2024 |
|
December 31, 2023 |
||
Assets |
|
|
|
||
Cash, cash equivalents and marketable securities |
$ |
6,524.5 |
|
$ |
11,218.3 |
Accounts receivable, net |
|
1,750.6 |
|
|
1,563.4 |
Inventories |
|
1,079.8 |
|
|
738.8 |
Prepaid expenses and other current assets |
|
449.2 |
|
|
623.7 |
Total current assets |
|
9,804.1 |
|
|
14,144.2 |
Property and equipment, net |
|
1,117.8 |
|
|
1,159.3 |
Goodwill and intangible assets, net |
|
1,919.6 |
|
|
1,927.9 |
Deferred tax assets |
|
2,308.9 |
|
|
1,812.1 |
Operating lease assets |
|
1,396.1 |
|
|
293.6 |
Long-term marketable securities |
|
4,703.5 |
|
|
2,497.8 |
Other long-term assets |
|
990.2 |
|
|
895.3 |
Total assets |
$ |
22,240.2 |
|
$ |
22,730.2 |
|
|
|
|
||
Liabilities and Shareholders' Equity |
|
|
|
||
Accounts payable and accrued expenses |
$ |
3,615.5 |
|
$ |
3,020.2 |
Other current liabilities |
|
357.6 |
|
|
527.2 |
Total current liabilities |
|
3,973.1 |
|
|
3,547.4 |
Long-term finance lease liabilities |
|
114.0 |
|
|
376.1 |
Long-term operating lease liabilities |
|
1,588.9 |
|
|
348.6 |
Other long-term liabilities |
|
933.3 |
|
|
877.7 |
Shareholders' equity |
|
15,630.9 |
|
|
17,580.4 |
Total liabilities and shareholders' equity |
$ |
22,240.2 |
|
$ |
22,730.2 |
|
|
|
|
||
Common shares outstanding |
|
257.7 |
|
|
257.7 |
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.
Vertex was founded in 1989 and has its global headquarters in
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief, or current expectation of Vertex and members of the Vertex senior management team. Forward-looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,” “expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning. Such statements include, without limitation, Dr. Kewalramani's statements in this press release, the information provided regarding future financial performance and operations, the section captioned “Full-Year 2024 Financial Guidance” and statements regarding (i) expectations for Vertex’s continued growth in CF, including through new approvals and reimbursements for the treatment of younger patients, (ii) the beliefs regarding anticipated benefits of CASGEVY, expectations for increasing numbers of patients initiating cell collection, and expectations with respect to international access and reimbursement for CASGEVY, (iii) expectations regarding the potential benefits and commercial success of suzetrigine for the treatment of moderate-to-severe acute pain, including beliefs regarding the efficacy and safety of suzetrigine, and beliefs that suzetrigine has potential to provide effective pain relief without the limitations of opioids and other available medicines, (iv) expectations and status of the potential near-term commercial launch of the vanzacaftor triple, and plans to continue to advance new oral small molecule combination therapies for the treatment of CF, (v) expectations for VX-522, including the potential benefits of this nebulized mRNA therapy and expectations to complete the Phase 1/2 study and share data in the first half of 2025, (vi) expectations regarding the SCD and TDT program, including expectations that a gentler conditioning for CASGEVY could broaden the eligible patient population, (vii) plans with respect to the studies of the intravenous and oral formulation of VX-993 for the treatment of acute pain, (viii) expectations regarding PNP patient populations, expectations to share results from the Phase 2 study of suzetrigine in LSR by the end of the year, and plans to continue to develop NaV1.8 and NaV1.7 inhibitors for both acute pain and PNP, (ix) expectations regarding the potential benefits of the AMKD program, including plans for the global Phase 2/3 pivotal clinical trial evaluating inaxaplin in patients with AMKD, (x) expectations with respect to povetacicept, including beliefs about its potential benefits and therapeutic scope, study designs, expectations that the interim analysis of this study may serve as the basis to seek accelerated approval in
Conference Call and Webcast
The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (833) 630-2124 (
The conference call will be webcast live and a link to the webcast can be accessed through Vertex's website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company's website.
(VRTX-E)
View source version on businesswire.com: https://www.businesswire.com/news/home/20241104366846/en/
Vertex Contacts:
Investor Relations:
Susie Lisa, CFA, 617-341-6108
Manisha Pai, 617-961-1899
Miroslava Minkova, 617-341-6135
Media:
617-341-6992
mediainfo@vrtx.com
Source: Vertex Pharmaceuticals Incorporated
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