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Puma Biotechnology Reports Second Quarter Financial Results

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Puma Biotechnology (NASDAQ: PBYI) reported its Q2 2024 financial results. Product revenue from NERLYNX® sales was $44.4 million, down from $51.6 million in Q2 2023. The company reported a net loss of $4.5 million, or $0.09 per share, compared to net income of $2.1 million in Q2 2023. Non-GAAP adjusted net loss was $2.5 million. Total revenue for Q2 2024 was $47.1 million, including $2.7 million in royalty revenue. Operating costs were $49.3 million. The company ended the quarter with $96.8 million in cash and equivalents. Puma anticipates key milestones in the next 12 months, including the initiation of ALISCA™-Breast1 trial and interim data from ALISCA™-Lung1 trial. The company provided guidance for Q3 and full-year 2024, projecting net product revenue of $183-$190 million for the year.

Puma Biotechnology (NASDAQ: PBYI) ha riportato i risultati finanziari del secondo trimestre del 2024. I ricavi da prodotto delle vendite di NERLYNX® sono stati di 44,4 milioni di dollari, in calo rispetto ai 51,6 milioni di dollari nel secondo trimestre del 2023. L'azienda ha registrato una perdita netta di 4,5 milioni di dollari, pari a 0,09 dollari per azione, rispetto a un utile netto di 2,1 milioni di dollari nel secondo trimestre del 2023. La perdita netta rettificata non-GAAP è stata di 2,5 milioni di dollari. I ricavi totali per il secondo trimestre del 2024 sono stati di 47,1 milioni di dollari, inclusi 2,7 milioni di dollari di ricavi da royalty. I costi operativi sono stati di 49,3 milioni di dollari. L'azienda ha chiuso il trimestre con 96,8 milioni di dollari in contante e equivalenti. Puma prevede traguardi chiave nei prossimi 12 mesi, incluso l'avvio dello studio ALISCA™-Breast1 e dati preliminari dallo studio ALISCA™-Lung1. L'azienda ha fornito indicazioni per il terzo trimestre e per l'intero anno 2024, prevedendo ricavi netti da prodotto tra 183 e 190 milioni di dollari per l'anno.

Puma Biotechnology (NASDAQ: PBYI) informó sobre sus resultados financieros del segundo trimestre de 2024. Los ingresos por productos de las ventas de NERLYNX® fueron de 44,4 millones de dólares, una disminución de 51,6 millones de dólares en el segundo trimestre de 2023. La compañía reportó una pérdida neta de 4,5 millones de dólares, o 0,09 dólares por acción, en comparación con una ganancia neta de 2,1 millones de dólares en el segundo trimestre de 2023. La pérdida neta ajustada no-GAAP fue de 2,5 millones de dólares. Los ingresos totales para el segundo trimestre de 2024 fueron de 47,1 millones de dólares, incluyendo 2,7 millones de dólares en ingresos por regalías. Los costos operativos fueron de 49,3 millones de dólares. La empresa terminó el trimestre con 96,8 millones de dólares en efectivo y equivalentes. Puma anticipa hitos clave en los próximos 12 meses, incluido el inicio del ensayo ALISCA™-Breast1 y datos interinos del ensayo ALISCA™-Lung1. La empresa proporcionó pronósticos para el tercer trimestre y el año completo de 2024, proyectando ingresos netos por productos de entre 183 y 190 millones de dólares para el año.

Puma Biotechnology (NASDAQ: PBYI)는 2024년 2분기 재무 결과를 발표했습니다. NERLYNX® 판매로 인한 제품 수익은 4440만 달러로, 2023년 2분기의 5160만 달러에서 감소했습니다. 회사는 450만 달러의 순손실을 기록했으며, 주당 0.09달러의 손실을 보였습니다. 이는 2023년 2분기의 210만 달러 순이익과 비교됩니다. 비-GAAP로 조정된 순손실은 250만 달러였습니다. 2024년 2분기 총 수익은 4710만 달러로, 이 중 270만 달러는 로열티 수익입니다. 운영 비용은 4930만 달러였습니다. 회사는 현금 및 현금 환산 자산으로 9680만 달러를 보유하고 2분기를 마감했습니다. Puma는 ALISCA™-Breast1 시험의 시작과 ALISCA™-Lung1 시험의 중간 데이터 발표를 포함하여 향후 12개월 이내에 주요 이정표를 예상하고 있습니다. 회사는 2024년 3분기 및 전체 연도에 대한 가이드를 제공하며, 연간 순 제품 수익을 1억8300만에서 1억9000만 달러로 예상하고 있습니다.

Puma Biotechnology (NASDAQ: PBYI) a publié ses résultats financiers pour le deuxième trimestre 2024. Les revenus liés aux produits issus des ventes de NERLYNX® se sont élevés à 44,4 millions de dollars, en baisse par rapport à 51,6 millions de dollars au deuxième trimestre 2023. L'entreprise a enregistré une perte nette de 4,5 millions de dollars, soit 0,09 dollar par action, contre un bénéfice net de 2,1 millions de dollars au deuxième trimestre 2023. La perte nette ajustée hors-GAAP était de 2,5 millions de dollars. Le chiffre d'affaires total pour le deuxième trimestre 2024 était de 47,1 millions de dollars, y compris 2,7 millions de dollars de revenus de redevances. Les coûts d'exploitation étaient de 49,3 millions de dollars. L'entreprise a terminé le trimestre avec 96,8 millions de dollars en liquidités et équivalents. Puma prévoit des jalons clés au cours des 12 prochains mois, y compris le lancement de l'essai ALISCA™-Breast1 et les données intermédiaires de l'essai ALISCA™-Lung1. L'entreprise a fourni des prévisions pour le troisième trimestre et pour l'ensemble de l'année 2024, projetant des revenus nets de produits de 183 à 190 millions de dollars pour l'année.

Puma Biotechnology (NASDAQ: PBYI) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 berichtet. Der Produktumsatz aus den Verkäufen von NERLYNX® betrug 44,4 Millionen Dollar, ein Rückgang von 51,6 Millionen Dollar im zweiten Quartal 2023. Das Unternehmen berichtete von einem Nettoverlust von 4,5 Millionen Dollar, oder 0,09 Dollar pro Aktie, verglichen mit einem Nettogewinn von 2,1 Millionen Dollar im zweiten Quartal 2023. Der nicht-GAAP-adjustierte Nettoverlust betrug 2,5 Millionen Dollar. Der Gesamtumsatz für das zweite Quartal 2024 belief sich auf 47,1 Millionen Dollar, einschließlich 2,7 Millionen Dollar an Lizenzgebühren. Die Betriebskosten lagen bei 49,3 Millionen Dollar. Das Unternehmen beendete das Quartal mit 96,8 Millionen Dollar in Bar und barähnlichen Mitteln. Puma erwartet in den nächsten 12 Monaten wichtige Meilensteine, einschließlich des Starts der ALISCA™-Breast1-Studie und der Zwischenanalyse der ALISCA™-Lung1-Studie. Das Unternehmen gab eine Prognose für das dritte Quartal und das Gesamtjahr 2024 ab und rechnet mit einem Nettoumsatz von 183 bis 190 Millionen Dollar für das Jahr.

Positive
  • Promising efficacy signals from alisertib combination study in lung cancer
  • Anticipated initiation of ALISCA™-Breast1 trial in Q4 2024
  • Expected interim data from ALISCA™-Lung1 trial in Q4 2024
  • Projected full-year 2024 net product revenue of $183-$190 million
  • Cash position of $96.8 million as of June 30, 2024
Negative
  • Product revenue decreased to $44.4 million in Q2 2024 from $51.6 million in Q2 2023
  • Net loss of $4.5 million in Q2 2024 compared to net income of $2.1 million in Q2 2023
  • Total revenue declined to $47.1 million in Q2 2024 from $54.6 million in Q2 2023
  • Non-GAAP adjusted net loss of $2.5 million in Q2 2024 versus $4.6 million income in Q2 2023

Puma Biotechnology's Q2 2024 results reveal a concerning trend in revenue decline and profitability challenges. The company reported a net loss of $4.5 million, or $0.09 per share, compared to a net income of $2.1 million in Q2 2023. This shift from profit to loss is significant and warrants investor attention.

Product revenue from NERLYNX®, Puma's primary commercial product, decreased by 13.95% year-over-year to $44.4 million. This decline in the company's main revenue driver is worrisome and may indicate market challenges or increased competition. The six-month figures show a similar trend, with product revenue down 13.94% to $84.6 million.

On a positive note, the company maintains a stable cash position with $96.8 million in cash and equivalents, slightly up from $96.0 million at the end of 2023. This provides some financial cushion as Puma navigates its current challenges.

Looking ahead, Puma's Q3 2024 outlook projects net product revenue between $50-53 million, suggesting a potential stabilization or slight improvement from Q2. However, the full-year 2024 projection of $183-190 million in net product revenue implies continued pressure compared to previous years.

Investors should closely monitor Puma's ability to reverse the revenue decline trend and return to profitability. The company's pipeline developments, particularly with alisertib, could be important for future growth prospects.

Puma Biotechnology's clinical developments present a mixed picture for investors. The company reported promising efficacy signals from the Phase I/Ib study of alisertib in combination with osimertinib for advanced osimertinib-resistant EGFR-mutated lung cancer. This is a potentially significant development, as resistance to osimertinib is a major challenge in lung cancer treatment.

The decision to amend the trial to focus on tp53 wild type patients demonstrates a strategic approach to biomarker-directed therapy. This could potentially increase the chances of success in future studies and make the treatment more targeted and effective.

The biomarker analysis from the Phase II trial of alisertib in endocrine and CDK4/6 inhibitor resistant breast cancer is also noteworthy. By identifying subsets of patients who may benefit most from alisertib, Puma could potentially position the drug more effectively in the competitive breast cancer market.

Key upcoming milestones include:

  • Initiation of ALISCA™-Breast1 Phase II trial (Q4 2024)
  • Interim data from ALISCA™-Lung1 Phase II trial (Q4 2024)

These milestones could provide important catalysts for the company's pipeline and stock performance. However, investors should note that clinical trial outcomes are inherently uncertain and positive results are not guaranteed.

While these developments are promising, they are still in early to mid-stage development. The company will need to successfully navigate later-stage trials and potential regulatory approvals before these pipeline assets can contribute to revenue. In the meantime, Puma remains heavily dependent on NERLYNX®, which is showing signs of sales decline.

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the second quarter ended June 30, 2024. Unless otherwise stated, all comparisons are for the second quarter 2024 compared to the second quarter 2023.

Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net in the second quarter of 2024 was $44.4 million, compared to product revenue, net of $51.6 million in the second quarter of 2023. Product revenue, net in the first six months of 2024 was $84.6 million, compared to $98.3 million in the first six months of 2023.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $4.5 million, or $0.09 per share, for the second quarter of 2024, compared to net income of $2.1 million, or $0.05 per basic and diluted share, for the second quarter of 2023. Net loss for the first six months of 2024 was $9.3 million, or $0.19 per share, compared to net income of $3.5 million, or $0.08 per basic share and $0.07 per diluted share, for the first six months of 2023.

Non-GAAP adjusted net loss was $2.5 million, or $0.05 per share, for the second quarter of 2024, compared to non-GAAP adjusted net income of $4.6 million, or $0.10 per basic and diluted share, for the second quarter of 2023. Non-GAAP adjusted net loss for the first six months of 2024 was $4.9 million, or $0.10 per share, compared to non-GAAP adjusted net income of $8.8 million, or $0.19 per basic and diluted share, for the first six months of 2023. Non-GAAP adjusted net (loss) income excludes stock-based compensation expense. For a reconciliation of GAAP net (loss) income to non-GAAP adjusted net (loss) income and GAAP net (loss) income per share to non-GAAP adjusted net (loss) income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the second quarter of 2024 was $1.0 million, compared to $3.3 million in the second quarter of 2023. Net cash provided by operating activities for the first six months of 2024 was $12.3 million, compared to net cash provided by operating activities of $5.9 million in the first six months of 2023. At June 30, 2024, Puma had cash, cash equivalents and marketable securities of $96.8 million, compared to cash, cash equivalents and marketable securities of $96.0 million at December 31, 2023.

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma, said, “We were pleased to see promising efficacy signals from the Phase I/Ib study of alisertib in combination with osimertinib in advanced osimertinib-resistant EGFR-mutated lung cancer, which was presented at the 2024 Annual Meeting of the American Society of Clinical Oncology. The trial has been amended such that future enrollment will be limited to patients who are tp53 wild type and we look forward to further studying this combination in this biomarker directed cohort of patients. In addition, the biomarker analysis from the Phase II randomized clinical trial of alisertib alone vs. alisertib + fulvestrant for the treatment of patients with endocrine and CDK4/6 inhibitor (CDK 4/6i) resistant, human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer, presented at the same conference, may provide clarity into the subset of patients who may derive the greatest benefit from treatment with alisertib.”

Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) initiation of 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) and (ii) interim data from ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2024).”

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX®, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the second quarter ended June 30, 2024, total revenue was $47.1 million, of which $44.4 million was net product revenue and $2.7 million was royalty revenue. This compares to total revenue for the second quarter of 2023 of $54.6 million, of which $51.6 million was net product revenue and $3.0 million was royalty revenue. For the first six months of 2024, total revenue was $90.8 million, of which $84.6 million was net product revenue and $6.2 million was royalty revenue. This compares to total revenue for the first six months of 2023 of $107.3 million, of which $98.3 million was net product revenue and $9.0 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $49.3 million for the second quarter of 2024, compared to $49.7 million for the second quarter of 2023. Operating costs and expenses in the first six months of 2024 were $95.3 million, compared to $98.0 million in the first six months of 2023.

Cost of Sales

Cost of sales was $10.7 million for the second quarter of 2024, compared to $11.9 million for the second quarter of 2023. Cost of sales was $21.4 million for the first six months of 2024, compared to $25.1 million for the first six months of 2023. The $3.7 million decrease in the first six months of 2024 resulted primarily from lower royalty expense resulting from decreased worldwide net sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $25.0 million for the second quarter of 2024, compared to $24.4 million for the second quarter of 2023. SG&A expenses for the first six months of 2024 were $46.7 million, compared to $46.8 million for the first six months of 2023. The decrease was primarily due to lower payroll costs related to lower headcount and recruiting related expenses, a decrease in credit losses due to collection on an overdue receivable, a decrease in stock-based compensation expense and a decrease in marketing costs, partially offset by an increase in legal fees.

Research and Development Expenses

Research and development (R&D) expenses were $13.6 million for the second quarter of 2024, compared to $13.4 million for the second quarter of 2023. R&D expenses for the first six months of 2024 were $27.2 million, compared to $26.1 million for the first six months of 2023. The $1.1 million year-over-year increase for the first six months resulted primarily from an increase in clinical trial expenses related to alisertib drug product procurement, as well as a one-time payroll-related expense.

Total Other Income (Expenses)

Total other expenses were $2.0 million for the second quarter of 2024, compared to $2.6 million for the second quarter of 2023. Total other expenses were $4.2 million for the first six months of 2024, compared to $5.4 million for the first six months of 2023. The $1.2 million year-over-year decrease in other expenses for the first six months of 2024 resulted primarily from higher interest income associated with higher interest rates in the current year.

Third Quarter and Full Year 2024 Financial Outlook

 

Third Quarter 2024

Full Year 2024

Net Product Revenue

$50 -53 million

$183 - $190 million

Royalty Revenue

$20 - $22 million

$30 - $33 million

License Revenue

$0 million

$1 - $2 million

Net Income

$11 - $13 million

$12 - $15 million

Gross to Net Adjustment

18.5% - 19.5%

21% - 22%

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 1, 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 U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA 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. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc.

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™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https://www.NERLYNX.com or by calling 1-855-816-5421.

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) U.S. Indication

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 ≥ 5% of patients) were as follows:

  • 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 third 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

CONSOLIDATED STATEMENTS OF OPERATIONS

(in millions except share and per share data)

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

June 30,

 

June 30,

 

2024

 

2023

 

2024

 

2023

(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenues:
Product revenue, net

$

44.4

 

$

51.6

 

$

84.6

 

$

98.3

 

Royalty revenue

 

2.7

 

 

3.0

 

 

6.2

 

 

9.0

 

Total revenue

 

47.1

 

 

54.6

 

 

90.8

 

 

107.3

 

Operating costs and expenses:
Cost of sales

 

10.7

 

 

11.9

 

 

21.4

 

 

25.1

 

Selling, general and administrative

 

25.0

 

 

24.4

 

 

46.7

 

 

46.8

 

Research and development

 

13.6

 

 

13.4

 

 

27.2

 

 

26.1

 

Total operating costs and expenses

 

49.3

 

 

49.7

 

 

95.3

 

 

98.0

 

(Loss) income from operations

 

(2.2

)

 

4.9

 

 

(4.5

)

 

9.3

 

Other income (expenses):
Interest income

 

1.2

 

 

0.7

 

 

2.2

 

 

1.2

 

Interest expense

 

(3.4

)

 

(3.4

)

 

(6.6

)

 

(6.6

)

Other income

 

0.2

 

 

0.1

 

 

0.2

 

 

 

Total other expenses

 

(2.0

)

 

(2.6

)

 

(4.2

)

 

(5.4

)

Net (loss) income before income taxes

$

(4.2

)

$

2.3

 

$

(8.7

)

$

3.9

 

Income tax expense

 

(0.3

)

 

(0.2

)

 

(0.6

)

 

(0.4

)

Net (loss) income

$

(4.5

)

$

2.1

 

$

(9.3

)

$

3.5

 

Net (loss) income per share of common stock—basic

$

(0.09

)

$

0.05

 

$

(0.19

)

$

0.08

 

Net (loss) income per share of common stock—diluted

$

(0.09

)

$

0.05

 

$

(0.19

)

$

0.07

 

Weighted-average shares of common stock outstanding—basic

 

48,292,414

 

 

46,759,062

 

 

48,240,835

 

 

46,697,912

 

Weighted-average shares of common stock outstanding—diluted

 

48,292,414

 

 

47,201,185

 

 

48,240,835

 

 

47,172,752

 

PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY

LIQUIDITY AND CAPITAL RESOURCES

(in millions)

 

 

 

 

 

 

June 30,

December 31,

 

 

2024

2023

(Unaudited)
 
Cash and cash equivalents

$

67.1

 

$

84.6

 

Marketable securities

 

29.7

 

 

11.4

 

Working capital

 

33.4

 

 

56.8

 

Long term debt

 

43.7

 

 

65.7

 

Stockholders' equity

 

48.5

 

 

53.4

 

 
 

Six Months

 

Six Months

Ended

 

Ended

June 30,

 

June 30,

2024

 

2023

(Unaudited)

 

(Unaudited)

Cash provided by (used in):
Operating activities

$

12.3

 

$

5.9

 

Investing activities

 

(18.4

)

 

(22.1

)

Financing activities

 

(11.3

)

 

 

 
Decrease in cash and cash equivalents, and restricted cash

$

(17.4

)

$

(16.2

)

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 (loss) and net income (loss) per share calculated in accordance with GAAP and as adjusted to remove the impact of stock-based compensation expense. For the three months and six months ended June 30, 2024, stock-based compensation represented approximately 5.3% and 6.0% of total selling, general and administrative expense and research and development expense, respectively, and 6.4% and 7.2% for the same periods in 2023. Puma’s management believes that these non-GAAP financial measures are useful to enhance understanding of Puma’s financial performance, are more indicative of its operational performance, and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
Reconciliation of GAAP Net (Loss) income to Non-GAAP Adjusted Net (Loss) Income and
GAAP Net (Loss) income Per Share to Non-GAAP Adjusted Net (Loss) Income Per Share
(in millions except share and per share data)
(Unaudited)
 
Three Months Ended June 30,

2024

2023

 

GAAP net (loss) income

$

(4.5

)

$

2.1

Adjustments:
Stock-based compensation -
Selling, general and administrative (1)

 

1.4

 

 

1.8

Research and development (2)

 

0.6

 

 

0.8

Non-GAAP adjusted net (loss) income

$

(2.5

)

$

4.6

 
GAAP net (loss) income per share—basic

$

(0.09

)

$

0.05

Adjustment to net (loss) income (as detailed above)

 

0.04

 

 

0.05

Non-GAAP adjusted basic net (loss) income per share

$

(0.05

)

(3

)

$

0.10

(4

)

 
GAAP net (loss) income per share—diluted

$

(0.09

)

$

0.05

Adjustment to net (loss) income (as detailed above)

 

0.04

 

 

0.05

Non-GAAP adjusted diluted net (loss) income per share

$

(0.05

)

(5

)

$

0.10

(6

)

 
Six Months Ended June 30,

2024

2023

 

GAAP net (loss) income

$

(9.3

)

$

3.5

Adjustments:
Stock-based compensation -
Selling, general and administrative (1)

 

2.8

 

 

3.7

Research and development (2)

 

1.6

 

 

1.6

Non-GAAP adjusted net (loss) income

$

(4.9

)

$

8.8

 
GAAP net (loss) income per share—basic

$

(0.19

)

$

0.08

Adjustment to net (loss) income (as detailed above)

 

0.09

 

 

0.11

Non-GAAP adjusted basic net (loss) income per share

$

(0.10

)

(3

)

$

0.19

(4

)

 
GAAP net (loss) income per share—diluted

$

(0.19

)

$

0.07

Adjustment to net (loss) income (as detailed above)

 

0.09

 

 

0.12

Non-GAAP adjusted diluted net (loss) income per share

$

(0.10

)

(5

)

$

0.19

(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 loss per share was calculated based on 48,292,414 and 48,240,835 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2024 respectively.
(4) Non-GAAP adjusted basic net income per share was calculated based on 46,759,062 and 46,697,912 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2023, respectively.
(5) Potentially dilutive common stock equivalents (stock options restricted stock units and warrants) were not included in this non-GAAP adjusted diluted net loss per share for the three and six months ended June 30, 2024, as these shares would be considered anti-dilutive.
(6) Non-GAAP adjusted diluted net income per share was calculated based on 47,201,185 and 47,172,752 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2023, respectively.

 

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500

info@pumabiotechnology.com

ir@pumabiotechnology.com

David Schull or Olipriya Das, Russo Partners, +1 212 845 4200

david.schull@russopartnersllc.com

olipriya.das@russopartnersllc.com

Source: Puma Biotechnology, Inc.

FAQ

What was Puma Biotechnology's (PBYI) product revenue for Q2 2024?

Puma Biotechnology's product revenue for Q2 2024 was $44.4 million, derived entirely from sales of NERLYNX®.

How did Puma Biotechnology's (PBYI) Q2 2024 net income compare to Q2 2023?

Puma Biotechnology reported a net loss of $4.5 million in Q2 2024, compared to a net income of $2.1 million in Q2 2023.

What is Puma Biotechnology's (PBYI) cash position as of June 30, 2024?

As of June 30, 2024, Puma Biotechnology had cash, cash equivalents, and marketable securities totaling $96.8 million.

What are the key milestones Puma Biotechnology (PBYI) anticipates in the next 12 months?

Puma anticipates initiating the ALISCA™-Breast1 trial in Q4 2024 and releasing interim data from the ALISCA™-Lung1 trial in Q4 2024.

What is Puma Biotechnology's (PBYI) net product revenue guidance for full-year 2024?

Puma Biotechnology projects net product revenue of $183-$190 million for the full year 2024.

PUMA BIOTECHNOLOGY INC

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