Puma Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results
- Positive net income of $12.3 million for Q4 and $21.6 million for full year 2023.
- Product revenue of $53.2 million for Q4 and $203.1 million for the year.
- Non-GAAP adjusted net income of $14.8 million for Q4 and $31.8 million for the year.
- Cash, cash equivalents, and marketable securities at $96.0 million as of December 31, 2023.
- None.
Insights
The reported financial results by Puma Biotechnology show a notable transition from a net loss in the fourth quarter of 2022 to a net income in the same period of 2023, suggesting a significant improvement in profitability. This is further substantiated by the year-over-year increase in net income for the full year. The company's ability to generate positive cash flow from operating activities, as opposed to using cash in the previous year, indicates improved operational efficiency and financial health. Additionally, the increase in cash reserves provides the company with more liquidity and potential for investment in growth opportunities.
However, the slight decrease in product revenue for the fourth quarter, despite a slight increase annually, may raise concerns about the sustainability of sales growth for NERLYNX®. The forecasted decrease in net product revenue for the first quarter and full year of 2024 could imply a cautious outlook and potential challenges in the market. Investors would need to consider the company's strategies to mitigate the impact of the higher gross-to-net adjustments and how they plan to sustain profitability amidst these challenges.
From a market perspective, Puma Biotechnology's focus on clinical development and upcoming milestones for their products, including alisertib, is a critical factor for future growth. The initiation and progression of clinical trials are pivotal events that can influence investor sentiment and the company's market value. The anticipated key milestones over the next 12 months could serve as catalysts for the company's stock performance, depending on the outcomes of these trials.
Furthermore, the increased royalty revenue contributes to a diversified revenue stream, which may be seen as a positive indicator of the company's licensing strategy and market reach. Understanding the competitive landscape and the potential market size for their treatments, particularly in the small cell lung cancer and breast cancer segments, is essential for evaluating the company's long-term prospects.
From a medical research standpoint, the development of alisertib represents a strategic move to expand Puma Biotechnology's oncology portfolio beyond NERLYNX®. The initiation of the ALISCA-Lung1 Phase II clinical trial and the upcoming presentations of biomarker studies are significant steps toward addressing extensive stage small cell lung cancer and hormone receptor-positive, HER2-negative breast cancer. The outcomes of these studies could potentially enhance the therapeutic landscape and offer new treatment options for patients.
It is important to note that the clinical success and regulatory approval of these drugs are crucial for the company's future revenue and growth. Delays or negative results could have adverse effects on the company's financial position and investor confidence. Conversely, positive trial results could lead to increased investment in R&D and potential partnerships or licensing agreements, driving further revenue growth and stock appreciation.
Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net for the fourth quarter of 2023 was
Based on accounting principles generally accepted in
Non-GAAP adjusted net income was
Net cash provided by operating activities for the fourth quarter of 2023 was
“We are pleased to report positive net income for both the fourth quarter and full year 2023,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “NERLYNX sales in the fourth quarter were negatively impacted by the lower enrollments seen in Q3, as well as a higher than expected gross to net for the quarter. We have continued to reduce our internal expenses to account for this higher gross to net and lower Q3 enrollments, as we recognize our fiscal responsibility to continue to be net income positive in 2024. Puma also continues to execute on the clinical development of alisertib, and in February, we were pleased to initiate ALISertib in CAncer (ALISCA-Lung1), a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer.”
Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) presentation of biomarker studies from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor positive, HER2-negative breast cancer (H1 2024); (ii) updated data from the clinical trial of alisertib in combination with osimertinib in patients with metastatic EGFR-mutant non small cell lung cancer who have developed osimertinib resistance (H1 2024); (iii) 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 (iv) 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 (H2 2024).”
Revenue
Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the fourth quarter of 2023, 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
Acquired In-Process Research and Development Expense
Puma recorded acquired in-process R&D expense related to an alisertib up-front payment of
Total Other Income (Expenses)
Total other expenses were
First Quarter 2024 and Full Year 2024 Financial Outlook
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First Quarter 2024 |
Full Year 2024 |
Net Product Revenue |
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Royalty Revenue |
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| License Revenue |
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Net Income/(Loss) |
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Gross to Net Adjustment |
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Conference Call
Puma Biotechnology will host a conference call to discuss its fourth quarter and full year 2023 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, February 29, 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 approximately one hour 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), PB272 (neratinib, intravenous) and PB357. 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.
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)
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 first 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 SUBSIDIARIES | |||||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
| (in millions except share and per share data) | |||||||||||||||||
| Three Months Ended | Twelve Months Ended | ||||||||||||||||
| December 31, | December 31, | ||||||||||||||||
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||||
| (Unaudited) | (Unaudited) | ||||||||||||||||
| Revenues: | |||||||||||||||||
| Product revenue, net | $ |
53.2 |
|
$ |
53.7 |
|
|
203.1 |
|
$ |
200.0 |
|
|||||
| License revenue |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|||||
| Royalty revenue |
|
19.0 |
|
|
12.0 |
|
|
32.5 |
|
|
28.0 |
|
|||||
| Total revenue |
|
72.2 |
|
|
65.7 |
|
|
235.6 |
|
|
228.0 |
|
|||||
| Operating costs and expenses: | |||||||||||||||||
| Cost of sales |
|
24.3 |
|
|
16.8 |
|
|
62.7 |
|
|
55.1 |
|
|||||
| Selling, general and administrative |
|
20.2 |
|
|
25.1 |
|
|
89.9 |
|
|
90.0 |
|
|||||
| Research and development |
|
12.9 |
|
|
13.8 |
|
|
50.4 |
|
|
52.2 |
|
|||||
| Acquired in-process research and development |
|
— |
|
|
— |
|
|
— |
|
|
7.0 |
|
|||||
| Total operating costs and expenses |
|
57.4 |
|
|
55.7 |
|
|
203.0 |
|
|
204.3 |
|
|||||
| Income from operations |
|
14.8 |
|
|
10.0 |
|
|
32.6 |
|
|
23.7 |
|
|||||
| Other income (expenses): | |||||||||||||||||
| Interest income |
|
0.7 |
|
|
0.6 |
|
|
2.6 |
|
|
0.8 |
|
|||||
| Interest expense |
|
(3.3 |
) |
|
(3.3 |
) |
|
(13.3 |
) |
|
(11.5 |
) |
|||||
| Legal verdict (expense) credit |
|
— |
|
|
(12.4 |
) |
|
— |
|
|
(12.5 |
) |
|||||
| Other income (expense) |
|
0.6 |
|
|
(0.2 |
) |
|
0.8 |
|
|
— |
|
|||||
| Total other expenses |
|
(2.0 |
) |
|
(15.3 |
) |
|
(9.9 |
) |
|
(23.2 |
) |
|||||
| Net income (loss) before income taxes |
|
12.8 |
|
|
(5.3 |
) |
|
22.7 |
|
|
0.5 |
|
|||||
| Income tax expense |
|
(0.5 |
) |
|
(0.3 |
) |
|
(1.1 |
) |
|
(0.5 |
) |
|||||
| Net income (loss) | $ |
12.3 |
|
$ |
(5.6 |
) |
$ |
21.6 |
|
$ |
(0.0 |
) |
|||||
| Net income (loss) per share of common stock—basic | $ |
0.26 |
|
$ |
(0.12 |
) |
$ |
0.46 |
|
$ |
0.00 |
|
|||||
| Net income (loss) per share of common stock—diluted | $ |
0.26 |
|
$ |
(0.12 |
) |
$ |
0.45 |
|
$ |
0.00 |
|
|||||
| Weighted-average shares of common stock outstanding—basic |
|
47,600,505 |
|
|
45,814,185 |
|
|
47,134,331 |
|
|
44,674,501 |
|
|||||
| Weighted-average shares of common stock outstanding—diluted |
|
48,040,118 |
|
|
45,814,185 |
|
|
47,550,852 |
|
|
44,929,998 |
|
|||||
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES
|
|||||||||
| December 31, | December 31, | ||||||||
|
2023 |
|
|
2022 |
|
||||
| Cash and cash equivalents | $ |
84.6 |
|
$ |
76.2 |
|
|||
| Marketable securities | $ |
11.4 |
|
$ |
4.9 |
|
|||
| Working capital | $ |
56.8 |
|
$ |
56.8 |
|
|||
| Short term debt | $ |
34.0 |
|
|
— |
|
|||
| Long term debt | $ |
65.7 |
|
$ |
98.3 |
|
|||
| Stockholders' deficit | $ |
53.4 |
|
$ |
21.6 |
|
|||
| Twelve Months | Twelve Months | ||||||||
| Ended | Ended | ||||||||
| December 31, | December 31, | ||||||||
|
2023 |
|
|
2022 |
|
||||
| Cash provided by (used in): | |||||||||
| Operating activities | $ |
27.0 |
|
$ |
(15.8 |
) |
|||
| Investing activities |
|
(19.1 |
) |
|
7.1 |
|
|||
| Financing activities |
|
— |
|
|
12.2 |
|
|||
| Increase (decrease) in cash and cash equivalents, and restricted cash | $ |
7.9 |
|
$ |
3.5 |
|
|||
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 twelve months ended December 31, 2023, stock-based compensation represented approximately
| PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES | |||||||||||||
| 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) | |||||||||||||
|
|||||||||||||
|
Three Months Ended December 31, | ||||||||||||
|
|
2023 |
|
2022 |
|
||||||||
GAAP net income (loss) |
$ |
12.3 |
$ |
(5.6 |
) |
||||||||
Adjustments: |
|||||||||||||
Stock-based compensation - |
|||||||||||||
Selling, general and administrative |
|
1.5 |
|
1.8 |
|
(1) |
|||||||
Research and development |
|
1.0 |
|
0.8 |
|
(2) |
|||||||
Non-GAAP adjusted net income (loss) |
$ |
14.8 |
$ |
(3.0 |
) |
||||||||
|
|||||||||||||
GAAP net income (loss) per share—basic |
$ |
0.26 |
$ |
(0.12 |
) |
||||||||
Adjustment to net income (loss) (as detailed above) |
|
0.05 |
|
0.05 |
|
||||||||
Non-GAAP adjusted basic net income (loss) per share |
$ |
0.31 |
(3) |
$ |
(0.07 |
) |
(3) |
||||||
|
|||||||||||||
GAAP net income (loss) per share—diluted |
$ |
0.26 |
$ |
(0.12 |
) |
||||||||
Adjustment to net income (loss) (as detailed above) |
|
0.05 |
|
0.05 |
|
||||||||
Non-GAAP adjusted diluted net income (loss) per share |
$ |
0.31 |
(4) |
$ |
(0.07 |
) |
(5) |
||||||
|
|||||||||||||
|
Twelve Months Ended December 31, | ||||||||||||
|
|
2023 |
|
2022 |
|
||||||||
GAAP net income (loss) |
$ |
21.6 |
$ |
0.0 |
|
||||||||
Adjustments: |
|||||||||||||
Stock-based compensation - |
|||||||||||||
Selling, general and administrative |
|
- |
|
8.0 |
|
(1) |
|||||||
Research and development |
|
- |
|
3.8 |
|
(2) |
|||||||
Non-GAAP adjusted net income |
$ |
21.6 |
$ |
11.8 |
|
||||||||
|
|||||||||||||
GAAP net income (loss) per share—basic |
$ |
0.46 |
$ |
0.00 |
|
||||||||
Adjustment to net income (loss) (as detailed above) |
|
0.22 |
|
0.26 |
|
||||||||
Non-GAAP adjusted basic net income per share |
$ |
0.68 |
(6) |
$ |
0.26 |
|
(6) |
||||||
|
|||||||||||||
GAAP net income (loss) per share—diluted |
$ |
0.45 |
$ |
0.00 |
|
||||||||
Adjustment to net income (loss) (as detailed above) |
|
0.22 |
|
0.26 |
|
||||||||
Non-GAAP adjusted diluted net income per share |
$ |
0.67 |
(7) |
$ |
0.26 |
|
(7) |
||||||
|
|||||||||||||
(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 (loss) per share was calculated based on 47,600,505 and 44,814,185 weighted-average shares of common stock outstanding for the three months ended December 31, 2023 and 2022, respectively. |
(4) |
Non-GAAP adjusted diluted net income per share was calculated based on 48,040,118 weighted average common shares outstanding and potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) for the three months ended December 31, 2023. |
(5) |
Potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) were not included in the non-GAAP adjusted diluted net loss as these shares would be considered anti-dilutive. |
(6) |
Non-GAAP adjusted basic net income per share was calculated based on 47,134,331 and 44,674,501 weighted-average shares of common stock outstanding for the years ended December 31, 2023 and 2022, respectively. |
(7) |
Non-GAAP adjusted diluted net income per share was calculated based on 47,550,852 and 44,929,998 weighted average common shares outstanding and potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) for the years ended December 31, 2023 and 2022, respectively. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240229975938/en/
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.
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