ImmunityBio Reports Third-Quarter 2024 Financial Results
ImmunityBio (NASDAQ: IBRX) reported Q3 2024 financial results, highlighting $6.0 million in net product revenue from ANKTIVA®, significantly up from $1.0 million in the previous quarter. The company secured coverage for over 200 million medical lives and received a J-code effective January 2025. ANKTIVA's shelf life was extended to three years with 125,000 doses available. The company submitted MAA applications in the UK and plans EU submission in Q4 2024. Financial results showed cash position of $130.4 million, with a net loss of $85.7 million compared to $95.6 million in Q3 2023. R&D expenses increased to $50.4 million, while SG&A expenses rose to $35.9 million.
ImmunityBio (NASDAQ: IBRX) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando 6,0 milioni di dollari di ricavi netti da prodotto per ANKTIVA®, un notevole aumento rispetto a 1,0 milioni di dollari nel trimestre precedente. L'azienda ha ottenuto copertura per oltre 200 milioni di vite mediche e ha ricevuto un codice J valido da gennaio 2025. La durata di conservazione di ANKTIVA è stata estesa a tre anni, con 125.000 dosi disponibili. L'azienda ha presentato domande MAA nel Regno Unito e pianifica la presentazione nell'UE nel quarto trimestre 2024. I risultati finanziari hanno mostrato una posizione di cassa di 130,4 milioni di dollari, con una perdita netta di 85,7 milioni di dollari rispetto a 95,6 milioni di dollari nel terzo trimestre 2023. Le spese per R&D sono aumentate a 50,4 milioni di dollari, mentre le spese SG&A sono salite a 35,9 milioni di dollari.
ImmunityBio (NASDAQ: IBRX) reportó los resultados financieros del tercer trimestre de 2024, destacando 6.0 millones de dólares en ingresos netos por producto de ANKTIVA®, un aumento significativo desde 1.0 millón de dólares en el trimestre anterior. La compañía aseguró cobertura para más de 200 millones de vidas médicas y recibió un código J que entrará en vigor en enero de 2025. La vida útil de ANKTIVA se extendió a tres años con 125,000 dosis disponibles. La compañía presentó solicitudes de MAA en el Reino Unido y planea presentar en la UE en el cuarto trimestre de 2024. Los resultados financieros mostraron una posición de efectivo de 130.4 millones de dólares, con una pérdida neta de 85.7 millones de dólares en comparación con 95.6 millones de dólares en el tercer trimestre de 2023. Los gastos de I+D aumentaron a 50.4 millones de dólares, mientras que los gastos de SG&A ascendieron a 35.9 millones de dólares.
ImmunityBio (NASDAQ: IBRX)가 2024년 3분기 재무 결과를 보고하며,600만 달러의 ANKTIVA®에서 발생한 순 수익을 강조했습니다. 이는 이전 분기의 100만 달러에서 크게 증가한 수치입니다. 회사는 2억 이상의 의료 생명에 대한 보장을 확보했으며 2025년 1월부터 유효한 J 코드를 받았습니다. ANKTIVA의 유통 기한은 3년으로 연장되었고, 125,000회의 용량이 제공됩니다. 회사는 영국에 MAA 신청서를 제출했으며 2024년 4분기에는 EU 제출을 계획하고 있습니다. 재무 결과는 1억 304만 달러의 현금 보유 상태를 나타냈으며, 2023년 3분기의 9,560만 달러와 비교해 8570만 달러의 순손실을 기록했습니다. R&D 비용은 5040만 달러로 증가했고, SG&A 비용은 3590만 달러로 상승했습니다.
ImmunityBio (NASDAQ: IBRX) a annoncé les résultats financiers du troisième trimestre 2024, mettant en évidence 6,0 millions de dollars de chiffre d'affaires net de produit provenant d'ANKTIVA®, en nette augmentation par rapport à 1,0 million de dollars au trimestre précédent. L'entreprise a obtenu une couverture pour plus de 200 millions de vies médicales et a reçu un code J valable à partir de janvier 2025. La durée de conservation d'ANKTIVA a été prolongée à trois ans avec 125 000 doses disponibles. L'entreprise a soumis des demandes MAA au Royaume-Uni et prévoit une soumission dans l'UE au quatrième trimestre 2024. Les résultats financiers ont montré une position de trésorerie de 130,4 millions de dollars, avec une perte nette de 85,7 millions de dollars par rapport à 95,6 millions de dollars au troisième trimestre 2023. Les dépenses de R&D ont augmenté à 50,4 millions de dollars, tandis que les dépenses SG&A ont augmenté à 35,9 millions de dollars.
ImmunityBio (NASDAQ: IBRX) hat die Finanzergebnisse für das 3. Quartal 2024 veröffentlicht und dabei 6,0 Millionen Dollar an Nettoumsatz aus ANKTIVA® hervorgehoben, was im Vergleich zu 1,0 Millionen Dollar im vorherigen Quartal einen erheblichen Anstieg darstellt. Das Unternehmen hat die Abdeckung für über 200 Millionen medizinische Lebensentitäten gesichert und erhielt einen J-Code, der ab Januar 2025 gültig ist. Die Haltbarkeit von ANKTIVA wurde auf drei Jahre verlängert, mit 125.000 verfügbaren Dosen. Das Unternehmen hat MAA-Anträge im Vereinigten Königreich eingereicht und plant die Einreichung in der EU im 4. Quartal 2024. Die Finanzergebnisse zeigten eine Bargeldposition von 130,4 Millionen Dollar, mit einem Nettoverlust von 85,7 Millionen Dollar im Vergleich zu 95,6 Millionen Dollar im 3. Quartal 2023. Die F&E-Ausgaben stiegen auf 50,4 Millionen Dollar, während die SG&A-Ausgaben auf 35,9 Millionen Dollar erhöht wurden.
- Net product revenue increased significantly to $6.0 million from $1.0 million in previous quarter
- Secured insurance coverage for over 200 million medical lives
- Extended ANKTIVA shelf life from two to three years with 125,000 doses available
- Reduced net loss to $85.7 million from $95.6 million year-over-year
- R&D expenses increased by $2.0 million to $50.4 million year-over-year
- SG&A expenses rose by $4.1 million to $35.9 million year-over-year
- Cash position decreased to $130.4 million from $267.4 million at end of 2023
- Total stockholders' deficit increased to $744.2 million from $585.9 million at end of 2023
Insights
The Q3 results show mixed signals. Product revenue of
ANKTIVA's market penetration shows promising momentum with coverage secured for over 200 million medical lives. The J-code approval effective January 2025 will streamline reimbursement processes, potentially accelerating adoption. Global expansion plans through UK and EU regulatory submissions could significantly expand the addressable market. The extended shelf life to 3 years and inventory of 125,000 doses demonstrates strong operational readiness. However, increasing SG&A expenses of
- ANKTIVA® received a J-code (HCPCS Level II Code) in October 2024, effective January 1, 2025.
-
ANKTIVA (FDA-approved and commercially available in the
U.S. since May 2024) is now widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies. -
ImmunityBio achieved a net product revenue of approximately
$6.0 million $1.0 million - ImmunityBio has extended the shelf life of ANKTIVA from two years to three years, with over 125,000 doses, providing ample product for the market and for clinical trials.
-
ImmunityBio submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) a Marketing Authorization Application (MAA) for ANKTIVA in the
United Kingdom on November 1, 2024. -
ImmunityBio intends to submit to the European Medicines Agency (EMA) an MAA for ANKTIVA in the European Union (EU) in Q4 2024, covering 30 countries, including 27 in the EU and 3 in the European Economic Area (
Iceland ,Norway ,Liechtenstein ).
“The
“The response from the urologists and clinical practices with regard to the utility of ANKTIVA in NMIBC CIS has been gratifying. ImmunityBio’s clinical trial in BCG naïve NMIBC is enrolling well, and clinical sites have been expanded from the
Third-Quarter Ended September 30, 2024 Financial Summary
Cash and Marketable Securities Position
As of September 30, 2024, the Company had consolidated cash and cash equivalents, and marketable securities of
Research and Development Expenses
Research and development (R&D) expenses increased
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased
Net Loss Attributable to ImmunityBio Common Stockholders
Net loss attributable to ImmunityBio common stockholders was
ImmunityBio, Inc. |
||||||||||||||||
Condensed Consolidated Statements of Operations |
||||||||||||||||
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
(in thousands, except per share amounts; unaudited) |
2024 |
2023 |
2024 |
2023 |
||||||||||||
Revenue |
|
|
|
|
||||||||||||
Product revenue, net |
$ |
5,954 |
|
$ |
— |
|
$ |
6,944 |
|
$ |
— |
|
||||
Other revenues |
|
152 |
|
|
82 |
|
|
249 |
|
|
483 |
|
||||
Total revenue |
|
6,106 |
|
|
82 |
|
|
7,193 |
|
|
483 |
|
||||
Operating costs and expenses |
|
|
|
|
||||||||||||
Cost of product revenue |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||||
Research and development (including amounts with related parties) |
|
50,443 |
|
|
48,402 |
|
|
154,923 |
|
|
180,834 |
|
||||
Selling, general and administrative (including amounts with related parties) |
|
35,916 |
|
|
31,816 |
|
|
127,052 |
|
|
96,510 |
|
||||
Total operating costs and expenses |
|
86,359 |
|
|
80,218 |
|
|
281,975 |
|
|
277,344 |
|
||||
Loss from operations |
|
(80,253 |
) |
|
(80,136 |
) |
|
(274,782 |
) |
|
(276,861 |
) |
||||
Other income (expense), net: |
|
|
|
|
||||||||||||
Interest and investment income, net |
|
1,798 |
|
|
35 |
|
|
6,788 |
|
|
647 |
|
||||
Change in fair value of warrant and derivative liabilities, and convertible note |
|
32,938 |
|
|
21,782 |
|
|
30,306 |
|
|
32,549 |
|
||||
Interest expense (including amounts with related parties) |
|
(29,322 |
) |
|
(35,021 |
) |
|
(88,599 |
) |
|
(97,072 |
) |
||||
Interest expense related to revenue interest liability |
|
(10,925 |
) |
|
— |
|
|
(28,154 |
) |
|
— |
|
||||
Other income (expense), net (including amounts with related parties) and equity method investments |
|
12 |
|
|
(2,302 |
) |
|
(25 |
) |
|
(9,701 |
) |
||||
Total other expense, net |
|
(5,499 |
) |
|
(15,506 |
) |
|
(79,684 |
) |
|
(73,577 |
) |
||||
Loss before income taxes and noncontrolling interests |
|
(85,752 |
) |
|
(95,642 |
) |
|
(354,466 |
) |
|
(350,438 |
) |
||||
Income tax expense |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||||
Net loss |
|
(85,752 |
) |
|
(95,642 |
) |
|
(354,466 |
) |
|
(350,438 |
) |
||||
Net loss attributable to noncontrolling interests, net of tax |
|
(23 |
) |
|
(60 |
) |
|
(64 |
) |
|
(634 |
) |
||||
Net loss attributable to ImmunityBio common stockholders |
$ |
(85,729 |
) |
$ |
(95,582 |
) |
$ |
(354,402 |
) |
$ |
(349,804 |
) |
||||
|
|
|
|
|
||||||||||||
Net loss per ImmunityBio common share – basic |
$ |
(0.12 |
) |
$ |
(0.19 |
) |
$ |
(0.52 |
) |
$ |
(0.77 |
) |
||||
Net loss per ImmunityBio common share – diluted |
$ |
(0.14 |
) |
$ |
(0.19 |
) |
$ |
(0.53 |
) |
$ |
(0.77 |
) |
||||
Weighted-average number of common shares used in computing net loss per share – basic |
|
695,895 |
|
|
498,375 |
|
|
685,261 |
|
|
454,994 |
|
||||
Weighted-average number of common shares used in computing net loss per share – diluted |
|
697,961 |
|
|
498,375 |
|
|
688,939 |
|
|
454,994 |
|
||||
ImmunityBio, Inc. |
||||||||
Selected Balance Sheet Data |
||||||||
|
Sept. 30,
|
December 31,
|
||||||
(in thousands) |
(Unaudited) |
|
||||||
Cash and cash equivalents, and marketable securities |
$ |
130,367 |
|
$ |
267,353 |
|
||
Total assets |
|
364,570 |
|
|
504,452 |
|
||
Total related-party debt |
|
699,118 |
|
|
681,537 |
|
||
Revenue interest liability |
|
273,657 |
|
|
155,415 |
|
||
Total liabilities |
|
1,108,732 |
|
|
1,090,389 |
|
||
Total stockholders’ deficit (including noncontrolling interests) |
|
(744,162 |
) |
|
(585,937 |
) |
||
Total liabilities and stockholders’ deficit |
|
364,570 |
|
|
504,452 |
|
||
ImmunityBio, Inc. |
||||||||||||||||
Summary Reconciliation of Cash Flows |
||||||||||||||||
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
(in thousands; unaudited) |
2024 |
2023 |
2024 |
2023 |
||||||||||||
|
|
|
|
|
||||||||||||
Cash (used in) provided by: |
|
|
|
|
||||||||||||
Net cash used in operating activities |
$ |
(98,763 |
) |
$ |
(87,403 |
) |
$ |
(306,092 |
) |
$ |
(251,486 |
) |
||||
Net cash provided by (used in) investing activities |
|
65,032 |
|
|
(15,631 |
) |
|
(22,080 |
) |
|
(32,719 |
) |
||||
Net cash provided by financing activities |
|
15,582 |
|
|
237,502 |
|
|
174,701 |
|
|
357,802 |
|
||||
Effect of exchange rate changes on cash and cash equivalents, and restricted cash |
|
11 |
|
|
(1 |
) |
|
(16 |
) |
|
(265 |
) |
||||
Net change in cash and cash equivalents, and restricted cash |
|
(18,138 |
) |
|
134,467 |
|
|
(153,487 |
) |
|
73,332 |
|
||||
Cash and cash equivalents, and restricted cash, beginning of period |
|
130,438 |
|
|
43,830 |
|
|
265,787 |
|
|
104,965 |
|
||||
Cash and cash equivalents, and restricted cash, end of period |
$ |
112,300 |
|
$ |
178,297 |
|
$ |
112,300 |
|
$ |
178,297 |
|
||||
About ANKTIVA
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding anticipated regulatory submissions and timing thereof, market access initiatives and coverage under medical reimbursement policies, shelf life of ANKTIVA and product supply, global expansion efforts, effectiveness of the permanent J-code for ANKTIVA, clinical trial plans and timing, market and prevalence data, the regulatory filing and review process and timing thereof, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this presentation that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions.
Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding commercial launch execution, success and timing, (ii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, review and approval process, (v) risks and uncertainties associated with third-party collaborations and agreements, (vi) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vii) potential delays in product availability and regulatory approvals, (viii) ImmunityBio’s ability to retain and hire key personnel, (ix) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (x) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xi) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiii) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112689334/en/
ImmunityBio, Inc.
Investors
Hemanth Ramaprakash, PhD, MBA
+1-858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Sarah Singleton
+1-415-290-8045
Sarah.Singleton@ImmunityBio.com
Source: ImmunityBio, Inc.
FAQ
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