Puma Biotechnology Reports First Quarter Financial Results
Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net in the first quarter of 2025 was
Based on accounting principles generally accepted in
Non-GAAP adjusted net income was
Net cash provided by operating activities for the first quarter of 2025 was
“We are pleased to report better than expected net income for the first quarter of 2025,” said
Revenue
Total revenue consists of product revenue, net from sales of NERLYNX and royalty revenue. For the first quarter ended
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 expenses were
Research and Development Expenses
Research and development expenses were
Total Other Income (Expenses)
Total other expenses were
Second Quarter and Full Year 2025 Financial Outlook
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Second Quarter 2025 |
Full Year 2025 (current) |
Full Year 2025 (previous) |
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Net Product Revenue |
$48–$50 million |
$192–$198 million |
$192–$198 million |
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Royalty Revenue |
$2–$3 million |
$20–$24 million |
$20–$24 million |
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License Revenue |
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Net Income/(Loss)* |
$4–$6 million |
$23–$28 million |
$23–$28 million |
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Gross to Net Adjustment |
20%–21.5% |
20.5%–21.5% |
20.5%–21.5% |
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*The outlook above does not include any adjustments for tax valuation allowance. |
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Conference Call
About
In
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
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 ≥ 5% of patients) were:
- 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
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 after 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 second quarter and full year 2025. 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
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CONSOLIDATED STATEMENTS OF OPERATIONS (in millions except share and per share data) |
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Three Months Ended |
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2025 |
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2024 |
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(Unaudited) |
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(Unaudited) |
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Revenues: |
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Product revenue, net |
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$ |
43.1 |
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$ |
40.3 |
|
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Royalty revenue |
|
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2.9 |
|
|
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3.5 |
|
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Total revenue |
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46.0 |
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|
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43.8 |
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Operating costs and expenses: |
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Cost of sales |
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10.6 |
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10.7 |
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Selling, general and administrative |
|
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17.6 |
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21.8 |
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Research and development |
|
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13.8 |
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13.6 |
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Total operating costs and expenses |
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42.0 |
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46.1 |
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Income (loss) from operations |
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4.0 |
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(2.3 |
) |
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Other income (expenses): |
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Interest income |
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1.1 |
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1.0 |
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Interest expense |
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(2.2 |
) |
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(3.4 |
) |
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Other income |
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0.4 |
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0.1 |
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Total other expenses, net |
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(0.7 |
) |
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(2.3 |
) |
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Net income (loss) before income taxes |
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3.3 |
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(4.6 |
) |
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Income tax expense |
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(0.3 |
) |
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(0.2 |
) |
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Net income (loss) |
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$ |
3.0 |
|
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$ |
(4.8 |
) |
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Net income (loss) per share of common stock—basic |
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$ |
0.06 |
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$ |
(0.10 |
) |
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Net income (loss) per share of common stock—diluted |
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$ |
0.06 |
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$ |
(0.10 |
) |
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Weighted-average shares of common stock outstanding—basic |
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49,595,697 |
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48,189,256 |
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Weighted-average shares of common stock outstanding—diluted |
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49,906,341 |
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48,189,256 |
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LIQUIDITY AND CAPITAL RESOURCES (in millions) |
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2025 |
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2024 |
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(Unaudited) |
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Cash and cash equivalents |
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$ |
63.0 |
|
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$ |
69.2 |
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Marketable securities |
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30.1 |
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31.7 |
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Working capital |
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45.8 |
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51.5 |
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Short term debt |
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45.3 |
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45.3 |
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Long term debt |
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10.6 |
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21.7 |
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Stockholders’ equity |
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97.1 |
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92.1 |
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Three Months Ended |
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Three Months Ended |
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(Unaudited) |
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(Unaudited) |
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Cash provided by (used in): |
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Operating activities |
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$ |
3.6 |
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$ |
11.3 |
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Investing activities |
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1.5 |
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(19.1 |
) |
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Financing activities |
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(11.3 |
) |
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— |
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Net decrease in cash, cash equivalents and restricted cash |
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$ |
(6.2 |
) |
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$ |
(7.8 |
) |
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 ended
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Reconciliation of GAAP Net Income (Loss) to Non-GAAP Adjusted Net Income (Loss) and GAAP Net Income (Loss) Per Share to Non-GAAP Adjusted Net Income (Loss) Per Share (in millions except share and per share data) (Unaudited) |
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Three Months Ended |
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2025 |
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2024 |
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GAAP net income (loss) |
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$ |
3.0 |
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$ |
(4.8 |
) |
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Adjustments: |
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Stock-based compensation - |
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Selling, general and administrative (1) |
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1.2 |
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1.5 |
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Research and development (2) |
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0.8 |
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0.9 |
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Non-GAAP adjusted net income (loss) |
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$ |
5.0 |
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$ |
(2.4 |
) |
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GAAP net income (loss) per share—basic |
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$ |
0.06 |
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$ |
(0.10 |
) |
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Adjustment to net income (loss) (as detailed above) |
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0.04 |
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0.05 |
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Non-GAAP adjusted basic net income (loss) per share |
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$ |
0.10 |
(3) |
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$ |
(0.05 |
) |
(3) |
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GAAP net income (loss) per share—diluted |
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$ |
0.06 |
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$ |
(0.10 |
) |
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Adjustment to net income (loss) (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 (loss) per share |
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$ |
0.10 |
(4) |
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$ |
(0.05 |
) |
(5) |
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(1) To reflect a non-cash charge to operating expense for selling, general, and administrative stock-based compensation. |
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(2) To reflect a non-cash charge to operating expense for research and development stock-based compensation. |
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(3) Non-GAAP adjusted basic net income (loss) per share was calculated based on 49,595,697 and 48,189,256 weighted-average shares of common stock outstanding for the three months ended |
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(4) Non-GAAP adjusted diluted net income per share was calculated based on 49,906,341 weighted-average shares of common stock outstanding for the three months ended |
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(5) Potentially dilutive common stock equivalents were not included in this non-GAAP adjusted diluted net loss per share for the three months ended |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250508718397/en/
info@pumabiotechnology.com
ir@pumabiotechnology.com
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
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