Puma Biotechnology Reports Third Quarter 2024 Financial Results
Puma Biotechnology (NASDAQ: PBYI) reported strong Q3 2024 financial results with total revenue of $80.5 million, including $56.1 million in product revenue from NERLYNX® and $24.4 million in royalty revenue. The company posted a net income of $20.3 million ($0.41 per share), up from $5.8 million in Q3 2023. Operating cash flow was $11.0 million, with cash and equivalents of $97 million. The company updated its full-year 2024 guidance, projecting net product revenue of $187-190 million and net income of $15-17 million.
Puma Biotechnology (NASDAQ: PBYI) ha riportato risultati finanziari solidi per il Q3 2024, con un fatturato totale di 80,5 milioni di dollari, di cui 56,1 milioni derivanti dalle vendite di NERLYNX® e 24,4 milioni dalle royalties. L'azienda ha registrato un utile netto di 20,3 milioni di dollari (0,41 dollari per azione), in aumento rispetto ai 5,8 milioni di dollari del Q3 2023. Il flusso di cassa operativo è stato di 11,0 milioni di dollari, con liquidità e equivalenti di 97 milioni di dollari. L'azienda ha aggiornato le previsioni per l'intero anno 2024, prevedendo un fatturato netto da prodotto di 187-190 milioni di dollari e un utile netto di 15-17 milioni di dollari.
Puma Biotechnology (NASDAQ: PBYI) reportó resultados financieros sólidos para el tercer trimestre de 2024 con ingresos totales de 80.5 millones de dólares, que incluyen 56.1 millones en ingresos por productos de NERLYNX® y 24.4 millones en ingresos por regalías. La compañía reportó un ingreso neto de 20.3 millones de dólares (0.41 dólares por acción), un aumento desde los 5.8 millones en el tercer trimestre de 2023. El flujo de caja operativo fue de 11.0 millones de dólares, con efectivo y equivalentes de 97 millones de dólares. La empresa actualizó su guía para el año completo 2024, proyectando ingresos netos por productos de 187-190 millones de dólares y un ingreso neto de 15-17 millones de dólares.
Puma Biotechnology (NASDAQ: PBYI)는 2024년 3분기에 총 수익 8,050만 달러를 기록하며 강력한 재무 실적을 발표했습니다. 여기에는 NERLYNX®에서 발생한 5,610만 달러의 제품 수익과 2,440만 달러의 로열티 수익이 포함됩니다. 회사는 순이익 2,030만 달러 (주당 0.41 달러)를 올렸으며, 이는 2023년 3분기 580만 달러에서 증가한 수치입니다. 운영 현금 흐름은 1,100만 달러였으며, 현금 및 현금성 자산은 9,700만 달러입니다. 회사는 2024년 전체 연도 가이드를 업데이트하여 순 제품 수익을 1억 8,700만에서 1억 9,000만 달러, 순이익을 1,500만에서 1,700만 달러로 예상했습니다.
Puma Biotechnology (NASDAQ: PBYI) a annoncé de solides résultats financiers pour le troisième trimestre 2024, avec des revenus totaux de 80,5 millions de dollars, dont 56,1 millions issus des ventes de NERLYNX® et 24,4 millions de dollars de revenus de redevances. L'entreprise a affiché un bénéfice net de 20,3 millions de dollars (0,41 dollar par action), en hausse par rapport à 5,8 millions de dollars au troisième trimestre 2023. Le flux de trésorerie d'exploitation s'élevait à 11,0 millions de dollars, avec des liquidités et équivalents de 97 millions de dollars. L'entreprise a mis à jour ses prévisions pour l'année complète 2024, prévoyant des revenus nets de produits de 187 à 190 millions de dollars et un bénéfice net de 15 à 17 millions de dollars.
Puma Biotechnology (NASDAQ: PBYI) hat starke Finanzzahlen für das 3. Quartal 2024 gemeldet, mit einem Gesamtumsatz von 80,5 Millionen Dollar, einschließlich 56,1 Millionen Dollar aus Produktumsätzen von NERLYNX® und 24,4 Millionen Dollar aus Lizenzgebühren. Das Unternehmen verzeichnete ein Nettoeinkommen von 20,3 Millionen Dollar (0,41 Dollar pro Aktie), ein Anstieg von 5,8 Millionen Dollar im 3. Quartal 2023. Der operative Cashflow betrug 11,0 Millionen Dollar, mit liquiden Mitteln und Äquivalenten in Höhe von 97 Millionen Dollar. Das Unternehmen hat seine Prognose für das Gesamtjahr 2024 aktualisiert und erwartet ein Nettoumsatz von 187-190 Millionen Dollar sowie ein Nettoergebnis von 15-17 Millionen Dollar.
- Q3 2024 total revenue increased to $80.5M from $56.1M in Q3 2023
- Net income grew significantly to $20.3M from $5.8M year-over-year
- Positive operating cash flow of $11.0M in Q3 2024
- Company raised full-year 2024 guidance for net income to $15-17M
- Royalty revenue increased substantially to $24.4M from $4.5M year-over-year
- Product revenue for first nine months of 2024 decreased to $140.8M from $149.9M in 2023
- Operating costs increased to $58.4M from $47.5M year-over-year
- Cost of sales rose significantly to $29.1M from $13.3M in Q3 2023
Insights
Strong Q3 2024 financial performance shows significant improvement with
Cash position remains stable at
The pipeline development of alisertib represents significant potential in two major oncology markets. The upcoming Phase II trials in HER2-negative breast cancer and small cell lung cancer could expand Puma's market beyond NERLYNX. The strategic focus on chemotherapy-naïve patients in breast cancer trials suggests positioning as an earlier-line treatment option, which could drive larger market opportunities if successful.
Clinical milestones in 2025 will be important for validating alisertib's efficacy. The
Product revenue, net consists entirely of sales revenue from NERLYNX®, Puma’s first commercial product. Product revenue, net in the third quarter of 2024 was
Based on accounting principles generally accepted in
Non-GAAP adjusted net income was
Net cash provided by operating activities for the third quarter of 2024 was
“We are pleased to announce both positive net income and positive operating cash flow for the third quarter of 2024,” said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. “In addition to our focus on the commercialization of NERLYNX, we are also continuing to make progress with the clinical development of alisertib for patients with extensive stage small cell lung cancer and patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer.”
Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) initiation of ALI-1201/ALISCA™-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2024); (ii) presentation of interim data from ALI-4201/ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2025); and (iii) presentation of interim data from ALISCA™-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (2025).”
Revenue
Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product and royalty revenue. For the third quarter of 2024, total revenue was
Operating Costs and Expenses
Total operating costs and expenses were
Cost of Sales
Cost of sales was
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses were
Research and Development Expenses
Research and development (R&D) expenses were
Total Other Income (Expenses)
Total other expenses were
Fourth Quarter and Full Year 2024 Financial Outlook
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Fourth Quarter 2024 |
Full Year 2024 (previous) |
Full Year 2024 (new) |
Net Product Revenue |
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Royalty Revenue |
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License Revenue |
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Net Income |
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Gross to Net Adjustment |
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Conference Call
Puma Biotechnology will host a conference call to report its third quarter 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, November 7, 2024. The call may be accessed by dialing 1 (877) 709-8150 (domestic) or 1 (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com. A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the
In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer.
Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.
INDICATIONS
- NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:
- As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Important Safety Information Regarding NERLYNX® (neratinib)
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
- Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
- Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (reported in ≥
- NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
- NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS:
- Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
- Strong or moderate CYP3A4 inducers: Avoid concomitant use.
- Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Puma’s anticipated milestones and estimates of future financial results for the fourth quarter and full year 2024. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in millions except share and per share data) |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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(Unaudited) |
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(Unaudited) |
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(Unaudited) |
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(Unaudited) |
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Revenues: | |||||||||||||||||
Product revenue, net | $ |
56.1 |
|
$ |
51.6 |
|
$ |
140.8 |
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$ |
149.9 |
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Royalty revenue |
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24.4 |
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4.5 |
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30.6 |
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13.6 |
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Total revenue |
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80.5 |
|
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56.1 |
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171.4 |
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163.5 |
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Operating costs and expenses: | |||||||||||||||||
Cost of sales |
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29.1 |
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13.3 |
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50.5 |
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38.4 |
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Selling, general and administrative |
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16.8 |
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22.8 |
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63.5 |
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69.7 |
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Research and development |
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12.5 |
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11.4 |
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39.8 |
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37.6 |
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Total operating costs and expenses |
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58.4 |
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47.5 |
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153.8 |
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145.7 |
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Income from operations |
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22.1 |
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8.6 |
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17.6 |
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17.8 |
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Other income (expenses): | |||||||||||||||||
Interest income |
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1.3 |
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0.7 |
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3.5 |
|
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1.9 |
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Interest expense |
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(3.1 |
) |
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(3.3 |
) |
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(9.8 |
) |
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(10.0 |
) |
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Legal verdict expense |
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— |
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— |
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— |
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— |
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Other income |
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0.3 |
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— |
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0.6 |
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0.1 |
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Total other expenses, net |
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(1.5 |
) |
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(2.6 |
) |
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(5.7 |
) |
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(8.0 |
) |
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Net income before income taxes | $ |
20.6 |
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$ |
6.0 |
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$ |
11.9 |
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$ |
9.8 |
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Income tax expense |
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(0.3 |
) |
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(0.2 |
) |
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(0.9 |
) |
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(0.5 |
) |
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Net income | $ |
20.3 |
|
$ |
5.8 |
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$ |
11.0 |
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$ |
9.3 |
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Net income per share of common stock—basic | $ |
0.41 |
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$ |
0.12 |
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$ |
0.23 |
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$ |
0.20 |
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Net income per share of common stock—diluted | $ |
0.41 |
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$ |
0.12 |
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$ |
0.22 |
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$ |
0.20 |
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Weighted-average shares of common stock outstanding—basic |
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49,008,464 |
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47,520,338 |
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48,498,579 |
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46,977,127 |
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Weighted-average shares of common stock outstanding—diluted |
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49,173,361 |
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47,819,234 |
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49,025,103 |
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47,397,209 |
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY | |||||||||||||||||
LIQUIDITY AND CAPITAL RESOURCES | |||||||||||||||||
(in millions) | |||||||||||||||||
September 30, |
December 31, |
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2024 |
2023 |
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(Unaudited) | |||||||||||||||||
Cash and cash equivalents | $ |
67.3 |
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$ |
84.6 |
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Marketable securities |
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29.5 |
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11.4 |
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Working capital |
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46.4 |
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56.8 |
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Long term debt |
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32.7 |
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65.7 |
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Stockholders' equity |
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71.1 |
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53.4 |
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Nine Months |
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Nine Months |
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Ended |
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Ended |
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September 30, |
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September 30, |
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2024 |
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2023 |
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(Unaudited) |
(Unaudited) |
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Cash provided by (used in): | |||||||||||||||||
Operating activities | $ |
23.3 |
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$ |
16.6 |
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Investing activities |
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(18.1 |
) |
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(11.0 |
) |
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Financing activities |
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(22.5 |
) |
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— |
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(Decrease) increase in cash and cash equivalents, | |||||||||||||||||
and restricted cash | $ |
(17.3 |
) |
$ |
5.6 |
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Use of Non-GAAP Measures
In addition to operating results as calculated in accordance with GAAP, Puma uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents Puma’s net income and net income per share calculated in accordance with GAAP and as adjusted to remove the impact of stock-based compensation expense. For the three months and nine months ended September 30, 2024, stock-based compensation represented approximately
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY | ||||||||||
Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income and | ||||||||||
GAAP Net Income Per Share to Non-GAAP Adjusted Net Income Per Share | ||||||||||
(in millions except share and per share data) | ||||||||||
(Unaudited) | ||||||||||
Three Months Ended September 30, |
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2024 |
2023 |
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GAAP net income | $ |
20.3 |
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$ |
5.8 |
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Adjustments: | ||||||||||
Stock-based compensation - | ||||||||||
Selling, general and administrative (1) |
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1.5 |
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1.8 |
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Research and development (2) |
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0.6 |
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0.8 |
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Non-GAAP adjusted net income | $ |
22.4 |
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$ |
8.3 |
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GAAP net income per share—basic | $ |
0.41 |
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$ |
0.12 |
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Adjustment to net income (as detailed above) |
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0.05 |
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0.06 |
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Non-GAAP adjusted basic net income per share | $ |
0.46 |
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(3 |
) |
$ |
0.18 |
(4 |
) |
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GAAP net income per share—diluted | $ |
0.41 |
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$ |
0.12 |
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Adjustment to net income (as detailed above) |
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0.04 |
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0.05 |
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Non-GAAP adjusted diluted net income per share | $ |
0.45 |
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(5 |
) |
$ |
0.17 |
(6 |
) |
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Nine Months Ended September 30, |
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2024 |
2023 |
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GAAP net income | $ |
11.0 |
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$ |
9.3 |
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Adjustments: | ||||||||||
Stock-based compensation - | ||||||||||
Selling, general and administrative (1) |
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4.3 |
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5.4 |
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Research and development (2) |
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2.2 |
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2.4 |
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Non-GAAP adjusted net income | $ |
17.5 |
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$ |
17.1 |
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GAAP net income per share—basic | $ |
0.23 |
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$ |
0.20 |
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Adjustment to net income (as detailed above) |
|
0.13 |
|
|
0.16 |
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Non-GAAP adjusted basic net income per share | $ |
0.36 |
|
(3 |
) |
$ |
0.36 |
(4 |
) |
|
GAAP net income per share—diluted | $ |
0.41 |
|
$ |
0.20 |
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Adjustment to net income (as detailed above) |
|
(0.05 |
) |
|
0.16 |
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Non-GAAP adjusted diluted net income per share | $ |
0.36 |
|
(5 |
) |
$ |
0.36 |
(6 |
) |
(1) To reflect a non-cash charge to operating expense for selling, general, and administrative stock-based compensation. | ||||||||
(2) To reflect a non-cash charge to operating expense for research and development stock-based compensation. | ||||||||
(3) Non-GAAP adjusted basic net income per share was calculated based on 49,008,464 and 48,498,579 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively. | ||||||||
(4) Non-GAAP adjusted basic net income per share was calculated based on 47,520,338 and 46,977,127 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2023, respectively. | ||||||||
(5) Non-GAAP adjusted diluted net income per share was calculated based on 49,173,361 and 49,025,103 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively. | ||||||||
(6) Non-GAAP adjusted diluted net income per share was calculated based on 47,819,234 and 47,397,209 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2023, respectively. | ||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107443147/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
Source: Puma Biotechnology, Inc.
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