Protagonist Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Protagonist Therapeutics (NASDAQ:PTGX) reported significant financial and operational achievements for Q4 and full year 2024. The company earned a $165.0 million milestone for icotrokinra in Q4 2024 and nominated PN-881 as a development candidate for oral IL-17 receptor antagonist.
Key financial highlights include cash position of $559.2 million as of December 31, 2024, providing runway through 2028. The company reported total license and collaboration revenue of $434.4 million for 2024, a significant increase from $60.0 million in 2023. Net income reached $275.2 million ($4.23 per diluted share) for 2024, compared to a net loss of $(79.0) million in 2023.
Important upcoming milestones include topline results for rusfertide Phase 3 VERIFY trial in polycythemia vera and icotrokinra Phase 2b ANTHEM trial in ulcerative colitis, both expected in March 2025.
Protagonist Therapeutics (NASDAQ:PTGX) ha riportato risultati finanziari e operativi significativi per il quarto trimestre e l'intero anno 2024. L'azienda ha guadagnato un milestone di $165,0 milioni per icotrokinra nel quarto trimestre 2024 e ha nominato PN-881 come candidato allo sviluppo per antagonista orale del recettore IL-17.
I principali punti salienti finanziari includono una posizione di cassa di $559,2 milioni al 31 dicembre 2024, che garantisce liquidità fino al 2028. L'azienda ha riportato un fatturato totale da licenze e collaborazioni di $434,4 milioni per il 2024, un aumento significativo rispetto ai $60,0 milioni del 2023. Il reddito netto ha raggiunto $275,2 milioni ($4,23 per azione diluita) per il 2024, rispetto a una perdita netta di $(79,0) milioni nel 2023.
Tra i traguardi importanti in arrivo ci sono i risultati principali per il trial di fase 3 VERIFY di rusfertide nella policitemia vera e il trial di fase 2b ANTHEM di icotrokinra nella colite ulcerosa, entrambi attesi per marzo 2025.
Protagonist Therapeutics (NASDAQ:PTGX) informó logros financieros y operativos significativos para el cuarto trimestre y el año completo 2024. La compañía ganó un hito de $165,0 millones por icotrokinra en el cuarto trimestre de 2024 y nominó a PN-881 como candidato al desarrollo para antagonista oral del receptor IL-17.
Los principales aspectos financieros incluyen una posición de efectivo de $559,2 millones al 31 de diciembre de 2024, proporcionando recursos hasta 2028. La compañía reportó ingresos totales por licencias y colaboraciones de $434,4 millones para 2024, un aumento significativo respecto a los $60,0 millones en 2023. El ingreso neto alcanzó $275,2 millones ($4,23 por acción diluida) para 2024, en comparación con una pérdida neta de $(79,0) millones en 2023.
Los hitos importantes que se avecinan incluyen los resultados principales del ensayo de fase 3 VERIFY de rusfertide en policitemia vera y el ensayo de fase 2b ANTHEM de icotrokinra en colitis ulcerosa, ambos esperados para marzo de 2025.
프로타고니스트 테라퓨틱스 (NASDAQ:PTGX)는 2024년 4분기 및 전체 연도에 대한 중요한 재무 및 운영 성과를 보고했습니다. 회사는 2024년 4분기에 icotrokinra에 대해 1억 6,500만 달러의 이정표를 달성했으며, PN-881을 경구 IL-17 수용체 길항제 개발 후보로 지명했습니다.
주요 재무 하이라이트에는 2024년 12월 31일 기준 5억 5,920만 달러의 현금 보유가 포함되어 있으며, 이는 2028년까지의 자금을 제공합니다. 회사는 2024년에 4억 3,440만 달러의 총 라이선스 및 협력 수익을 보고했으며, 이는 2023년의 6천만 달러에서 크게 증가한 수치입니다. 2024년 순이익은 2억 7,520만 달러($4.23의 희석 주당 수익)로, 2023년의 순손실 $(7,900만)과 비교됩니다.
중요한 다가오는 이정표에는 다혈구증가증에서 rusfertide 3상 VERIFY 시험의 주요 결과와 궤양성 대장염에서 icotrokinra 2b ANTHEM 시험의 주요 결과가 포함되며, 두 가지 모두 2025년 3월에 예상됩니다.
Protagonist Therapeutics (NASDAQ:PTGX) a rapporté des réalisations financières et opérationnelles significatives pour le quatrième trimestre et l'année complète 2024. L'entreprise a gagné un jalon de 165,0 millions de dollars pour icotrokinra au quatrième trimestre 2024 et a nommé PN-881 comme candidat au développement pour un antagoniste oral du récepteur IL-17.
Les principaux points financiers incluent une position de trésorerie de 559,2 millions de dollars au 31 décembre 2024, offrant des ressources jusqu'en 2028. L'entreprise a rapporté des revenus totaux de licences et de collaborations de 434,4 millions de dollars pour 2024, une augmentation significative par rapport à 60,0 millions de dollars en 2023. Le revenu net a atteint 275,2 millions de dollars (4,23 dollars par action diluée) pour 2024, contre une perte nette de $(79,0) millions en 2023.
Les jalons importants à venir incluent les résultats principaux de l'essai de phase 3 VERIFY de rusfertide dans la polycythémie vera et l'essai de phase 2b ANTHEM d'icotrokinra dans la colite ulcéreuse, tous deux attendus en mars 2025.
Protagonist Therapeutics (NASDAQ:PTGX) berichtete von bedeutenden finanziellen und operativen Erfolgen für das vierte Quartal und das gesamte Jahr 2024. Das Unternehmen erzielte einen Meilenstein von 165,0 Millionen US-Dollar für icotrokinra im vierten Quartal 2024 und nominierte PN-881 als Entwicklungskandidaten für einen oralen IL-17-Rezeptor-Antagonisten.
Wichtige finanzielle Höhepunkte umfassen eine Liquiditätsposition von 559,2 Millionen US-Dollar zum 31. Dezember 2024, die bis 2028 reicht. Das Unternehmen berichtete von Gesamteinnahmen aus Lizenzen und Kooperationen in Höhe von 434,4 Millionen US-Dollar für 2024, ein erheblicher Anstieg von 60,0 Millionen US-Dollar im Jahr 2023. Der Nettogewinn erreichte 275,2 Millionen US-Dollar (4,23 US-Dollar pro verwässerter Aktie) für 2024, verglichen mit einem Nettoverlust von $(79,0) Millionen im Jahr 2023.
Wichtige bevorstehende Meilensteine sind die Hauptresultate der Phase-3-VERIFY-Studie zu rusfertide bei Polycythaemia vera und der Phase-2b-ANTHEM-Studie zu icotrokinra bei Colitis ulcerosa, die beide für März 2025 erwartet werden.
- Earned $165.0 million milestone payment for icotrokinra in Q4 2024
- Strong cash position of $559.2 million plus $165.0 million milestone payment
- Revenue increased to $434.4 million in 2024 from $60.0 million in 2023
- Net income of $275.2 million in 2024 versus $79.0 million loss in 2023
- Secured $300.0 million upfront payment from Takeda collaboration agreement
- R&D expenses increased by $18.0 million for full year 2024
- G&A expenses increased by $10.0 million for full year 2024
Insights
Protagonist Therapeutics has demonstrated remarkable financial transformation in 2024, with several elements positioning it for significant growth potential. The company's financial position shows exceptional strength with
The revenue structure reveals sophisticated deal-making capabilities: The Takeda collaboration for rusfertide includes a unique flexibility mechanism with a 50:50 profit share in the U.S. and an opt-out provision that could yield up to
Two critical near-term catalysts in March 2025 could fundamentally reshape the company's valuation:
- Rusfertide Phase 3 VERIFY results in polycythemia vera
- Icotrokinra Phase 2b ANTHEM results in ulcerative colitis
The company's R&D investment increase of
The transition to profitability is particularly noteworthy, with net income reaching
PN-881, a potential best-in-class oral IL-17 receptor antagonist peptide nominated as a development candidate in Q4 2024
Topline results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera expected in March 2025
Topline results for icotrokinra Phase 2b ANTHEM clinical trial in moderate to severe ulcerative colitis expected in March 2025
Cash, cash equivalents, and marketable securities of
NEWARK, CA / ACCESS Newswire / February 21, 2025 / Protagonist Therapeutics (NASDAQ:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update.
"Protagonist is quickly approaching multiple late-stage transformational events expected in the first quarter of this year, including the topline results from the VERIFY Phase 3 study of rusfertide in polycythemia vera and from the ANTHEM Phase 2b ulcerative colitis study of icotrokinra," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "In addition, we look forward to progressing oral IL-17 peptide antagonist PN-881 in clinical studies and nominating new development candidates from the oral obesity and oral hepcidin programs this year. We are fortunate to be in a strong cash position, enabling the flexibility to progress these early-stage peptide drug candidates independently into pre-clinical and clinical proof-of-concept studies over the coming years."
2024 Key Highlights
Worldwide License and Collaboration Agreement for Rusfertide with Takeda
On January 31, 2024, the Company and Takeda announced a worldwide license and collaboration agreement for rusfertide (the "Takeda License and Collaboration Agreement"). The Company received an upfront cash payment of
$300.0 million in April 2024 and is eligible to receive up to$330.0 million in development, regulatory, and sales milestones, for a potential deal value of up to$630.0 million , as well as an equal share of profits and losses in the U.S. and royalties on net sales outside the U.S.Under the terms of the agreement, the Company has the right to opt-out of the 50:50 profit share after NDA filing. In that event, the Company would be eligible to receive opt-out fees of up to
$400 million and enhanced milestones of up to$975 million , as well as royalties on worldwide net sales. Takeda would maintain full ex-U.S. rights under either scenario.
Two articles published in the New England Journal of Medicine ("NEJM") in February 2024
On February 7, 2024, the icotrokinra Phase 2b FRONTIER 1 trial results in adults living with moderate-to-severe plaque psoriasis were published in the NEJM.
On February 21, 2024, the complete Phase 2 REVIVE trial results for rusfertide, including efficacy and safety, were published in the NEJM.
S&P SmallCap 600 Index
The Company joined the Index on July 3, 2024.
Icotrokinra: Oral IL-23 Receptor Antagonist
Positive topline results for the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies1in moderate to severe plaque psoriasis, were reported in Q4 2024.
In the ICONIC-LEAD study, once-daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. At week 16, nearly two-thirds (
64.7% ) of patients treated with icotrokinra achieved IGA3 scores of 0/1 (clear or almost clear skin), and49.6% achieved PASI 90, compared to8.3% and4.4% on placebo, respectively. Further increases in response rates continued to be observed at week 24, with74.1% of patients treated with icotrokinra achieving IGA scores of 0/1, and64.9% achieving PASI 90. Safety data was consistent with the Phase 2 FRONTIER 1 and 2 studies.A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo, with
49.3% and49.1% of participants experiencing a treatment emergent adverse event (TEAE) at week 16. In addition, positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo.
Nomination of PN-881, a potential best-in-class oral peptide IL-17 antagonist development candidate; additional discovery programs announced
On November 21, 2024, the Company announced the nomination of PN-881 following extensive preclinical studies, including oral stability, potency, tissue distribution, and pharmacokinetics measurements, and evaluation in immunologic pharmacodynamics and preclinical efficacy models. PN-881 demonstrated in vitro blockade of IL-17 AA homodimer, FF homodimer and AF heterodimer. It demonstrated approximately 100-fold greater potency than secukinumab, and similar potency to the most potent approved antibody drugs and nanobody therapeutics currently in development.
The Company expects to nominate an oral development candidate in the hepcidin mechanism-based hematology program in Q4 2025, and an oral peptide-based development candidate in the metabolic/obesity program in Q2 2025.
Achievement of a
Under the terms of the icotrokinra license and collaboration agreement with JNJ, as amended in November 2024, the Company earned a
Recent and Upcoming Milestones
Rusfertide
Protagonist held an in-person PV Day on February 6, 2025, in New York; a replay of the webcast is available at https://lifescievents.com/event/protagonist/.
The topline data for the Phase 3 VERIFY study2 in PV, which has a 32-week primary efficacy endpoint, is expected in March of 2025.
Icotrokinra
Topline results for the Phase 2b ANTHEM multicenter, randomized, placebo-controlled, dose-ranging study of icotrokinra for the treatment of moderately to severely active ulcerative colitis3, are expected in March 2025.
Topline results for the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority studies4, evaluating the safety and efficacy of icotrokinra compared with both placebo and deucravacitinib in moderate to severe plaque psoriasis, are expected in Q2 2025.
Further details of the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies are expected to be presented at major medical conferences this year.
Discovery Programs
The Company expects to nominate an oral peptide-based development candidate in the obesity program in Q2 2025, and an oral development candidate in the hepcidin mechanism-based hematology program in Q4 2025.
Fourth Quarter and Full Year 2024 Financial Results
Cash, Cash Equivalents, and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2024, were
| Three Months Ended |
|
| Twelve Months Ended |
| |||||||||||
| December 31, |
|
| December 31, |
| |||||||||||
(in thousands, except per share amounts) |
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| ||||
License and collaboration revenue |
| $ | 170,638 |
|
| $ | 60,000 |
|
| $ | 434,433 |
|
| $ | 60,000 |
|
Research and development expense |
| $ | 34,904 |
|
| $ | 28,899 |
|
| $ | 138,128 |
|
| $ | 120,161 |
|
General and administrative expense |
| $ | 8,954 |
|
| $ | 8,052 |
|
| $ | 43,462 |
|
| $ | 33,491 |
|
Net income (loss) |
| $ | 131,674 |
|
| $ | 27,335 |
|
| $ | 275,188 |
|
| $ | (78,955 | ) |
Basic earnings (loss) per share |
| $ | 2.11 |
|
| $ | 0.45 |
|
| $ | 4.47 |
|
| $ | (1.39) |
|
Diluted earnings (loss) per share |
| $ | 1.98 |
|
| $ | 0.44 |
|
| $ | 4.23 |
|
| $ | (1.39) |
|
Revenue: License and collaboration revenue is derived from the Company's License and Collaboration Agreement with Johnson & Johnson (JNJ), as amended in November 2024 (the "JNJ Agreement"), and its Worldwide License and Collaboration Agreement for rusfertide with Takeda which became effective in March 2024 (the "Takeda Agreement"). Total License and collaboration revenue increased by
Revenue recorded during the year ended December 31, 2024, pursuant to the Takeda Agreement, of
$269.4 million ; andRevenue from the JNJ Agreement which increased by
$105.0 million for the year ended December 31, 2024, as compared to the prior year. The revenue reflects the achievement of non-refundable milestones of$165.0 million and$60.0 million for the years ended December 31, 2024, and 2023, respectively.
Research and Development ("R&D") Expenses: Increased by
General and Administrative ("G&A") Expenses: Increased by
Net Income (Loss): Net income was
About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to JNJ Innovative Medicines ("JNJ"), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, oral hepcidin program, and oral obesity program.
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of icotrokinra and rusfertide, the timing of icotrokinra and rusfertide clinical trials, and timing of developments and announcements in our discovery programs. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
Contact Information
Corey Davis Ph.D.
Investor Relations Contact - LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
Virginia Amann
Media Relations Contact - ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1
PROTAGONIST THERAPEUTICS, INC.
Consolidated Statements of Operations
(Amounts in thousands except share and per share data)
| Three Months Ended |
|
| Twelve Months Ended |
| |||||||||
| December 31, |
|
| December 31, |
| |||||||||
| 2024 |
| 2023 |
|
| 2024 |
| 2023 |
| |||||
License and collaboration revenue |
| $ | 170,638 |
| $ | 60,000 |
|
| $ | 434,433 |
| $ | 60,000 |
|
Operating expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
| 34,904 |
|
| 28,899 |
|
|
| 138,128 |
|
| 120,161 |
|
General and administrative (1) |
|
| 8,954 |
|
| 8,052 |
|
|
| 43,462 |
|
| 33,491 |
|
Total operating expense |
|
| 43,858 |
|
| 36,951 |
|
|
| 181,590 |
|
| 153,652 |
|
Income (loss) from operations |
|
| 126,780 |
|
| 23,049 |
|
|
| 252,843 |
|
| (93,652 | ) |
Interest income |
|
| 6,853 |
|
| 4,242 |
|
|
| 26,315 |
|
| 14,898 |
|
Other income (expense), net |
|
| 31 |
|
| 44 |
|
|
| 250 |
|
| (201 | ) |
Income (loss) before income tax expense |
|
| 133,664 |
|
| 27,335 |
|
|
| 279,408 |
|
| (78,955 | ) |
Income tax expense |
|
| 1,990 |
|
| - |
|
|
| 4,220 |
|
| - |
|
Net income (loss) |
| $ | 131,674 |
| $ | 27,335 |
|
| $ | 275,188 |
| $ | (78,955 | ) |
Net income (loss) per share, basic |
| $ | 2.11 |
| $ | 0.45 |
|
| $ | 4.47 |
| $ | (1.39 | ) |
Net income (loss) per share, diluted |
| $ | 1.98 |
| $ | 0.44 |
|
| $ | 4.23 |
| $ | (1.39 | ) |
Weighted-average shares used to compute net income (loss) per share, basic |
|
| 62,328,468 |
|
| 60,387,606 |
|
|
| 61,566,989 |
|
| 56,763,559 |
|
Weighted-average shares used to compute net income (loss) per share, diluted |
|
| 66,406,817 |
|
| 61,796,205 |
|
|
| 65,077,722 |
|
| 56,763,559 |
|
(1) Amount includes non-cash stock-based compensation expense.
Stock-based Compensation
(In thousands)
| Three Months Ended |
|
| Twelve Months Ended |
| |||||||||||
| December 31, |
|
| December 31, |
| |||||||||||
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| |||||
Research and development |
| $ | 5,322 |
|
| $ | 3,890 |
|
| $ | 20,919 |
|
| $ | 17,061 |
|
General and administrative |
|
| 3,771 |
|
|
| 2,711 |
|
|
| 16,635 |
|
|
| 12,232 |
|
Total stock-based compensation expense |
| $ | 9,093 |
|
| $ | 6,601 |
|
| $ | 37,554 |
|
| $ | 29,293 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
| December 31, |
| December 31, | |||||
| 2024 |
|
|
|
| |||
Cash, cash equivalents and marketable securities |
| $ | 559,165 |
|
| $ |
|
|
Working capital |
|
| 544,243 |
|
|
| 334,303 |
|
Total assets |
|
| 744,725 |
|
|
| 357,951 |
|
Deferred revenue |
|
| 30,567 |
|
|
| - |
|
Accumulated deficit |
|
| (340,522 | ) |
|
| (615,710 | ) |
Total stockholders' equity |
|
| 675,295 |
|
|
| 336,677 |
|
|
|
|
|
|
|
|
| |
1 ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
2 VERIFY (NCT05210790)
3 ANTHEM (NCT06049017)
4 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
SOURCE: Protagonist Therapeutics
View the original press release on ACCESS Newswire
FAQ
What were Protagonist's (PTGX) Q4 2024 financial results?
When will PTGX announce topline results for rusfertide Phase 3 VERIFY trial?
What is the value of Protagonist's Takeda collaboration agreement for rusfertide?
What was PTGX's revenue growth from 2023 to 2024?
When will Protagonist report icotrokinra Phase 2b ANTHEM trial results?
