Puma Biotechnology Reports First Quarter Financial Results
Puma Biotechnology, Inc. (NASDAQ: PBYI) reported its first quarter financial results for 2024, with $40.3 million in product revenue, a net loss of $4.8 million, and $107.2 million in cash reserves. Key milestones include clinical trials for lung and breast cancer treatments. Total revenue was $43.8 million, with operating costs of $46.1 million. Second quarter and full-year 2024 financial outlook projects net product revenue of $43-45 million and $183-190 million, respectively.
Strong product revenue performance despite a slight decrease year-over-year.
Successful initiation of Phase II clinical trial for lung cancer treatment and upcoming presentations of updated data.
A positive outlook with key milestones planned for the next 12 months, aiming for positive net income.
Increase in net cash provided by operating activities compared to the same period last year.
Net loss reported for the first quarter of 2024, compared to net income in the first quarter of 2023.
Decrease in non-GAAP adjusted net income for the first quarter of 2024 compared to the same period in 2023.
Reduction in total revenue compared to the first quarter of 2023, primarily due to lower royalty revenue.
Operating costs exceeding total revenue, leading to a negative financial outcome for the quarter.
Insights
The reported decrease in net product revenue, from
The financial outlook for the second quarter and full year 2024 provided by Puma forecasts a tight range of expected revenue and a return to positive net income. This could indicate management's confidence in the company's strategic direction, although the projected net income of
From an investment perspective, the reduction in operating expenses could be seen as a positive step towards optimizing cost structures. However, the increase in R&D expenses, although modest, reflects ongoing investment in the clinical development of alisertib. Seeing R&D as an essential driver for long-term growth, stakeholders might view these expenses as necessary for future revenue streams, yet it adds a layer of risk due to the uncertain outcomes of clinical trials.
The initiation of the ALISertib in CAncer (ALISCA-Lung1) trial represents a strategic pivot towards expanding Puma's oncology pipeline. Clinical developments in extensive stage small cell lung cancer, an area with significant unmet medical needs, could lead to future revenue drivers for the company. However, the inherent unpredictability of clinical trial outcomes means the impact on the company's financials remains speculative until further conclusive results are present.
Additionally, the emphasis on the development of alisertib, coupled with Puma's focus on managing resources to achieve positive net income, suggests an internal confidence in the drug's prospects. Market watchers will be interested in the updated data presentation at the American Society of Clinical Oncology (ASCO) meeting, as positive outcomes might catalyze investor enthusiasm and could potentially lead to future partnership or licensing opportunities, which would be a boon for revenue diversification.
The pharmaceutical industry is highly sensitive to clinical trial results and regulatory approvals. Investors should note the timeframes for the anticipated milestones and prepare for volatility around these periods, as any negative results could significantly impact the company's valuation.
Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net in the first quarter of 2024 was
Based on accounting principles generally accepted in
Non-GAAP adjusted net loss was
Net cash provided by operating activities for the first quarter of 2024 was
“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,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “We also look forward to presenting 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, as well as results from the biomarker studies of the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor-positive, HER2-negative breast cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting. We remain committed to our goal to clinically develop alisertib, while carefully managing our resources to achieve positive net income for this year.”
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 (Q2 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 (Q2 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 (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 first quarter ended March 31, 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 expenses were
Research and Development Expenses
Research and development expenses were
Total Other Income (Expenses)
Total other expenses were
Second Quarter and Full Year 2024 Financial Outlook
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Second 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 report its first quarter 2024 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 2, 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) 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-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)
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 second 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 | ||||||||
| March 31, | ||||||||
2024 |
2023 |
|||||||
| (Unaudited) | (Unaudited) | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ |
40.3 |
|
$ |
46.8 |
|
||
| License revenue |
|
— |
|
|
— |
|
||
| Royalty revenue |
|
3.5 |
|
|
6.0 |
|
||
| Total revenue |
|
43.8 |
|
|
52.8 |
|
||
| Operating costs and expenses: | ||||||||
| Cost of sales |
|
10.7 |
|
|
13.2 |
|
||
| Selling, general and administrative |
|
21.8 |
|
|
22.5 |
|
||
| Research and development |
|
13.6 |
|
|
12.7 |
|
||
| Total operating costs and expenses |
|
46.1 |
|
|
48.4 |
|
||
| (Loss) income from operations |
|
(2.3 |
) |
|
4.4 |
|
||
| Other expenses: | ||||||||
| Interest income |
|
1.0 |
|
|
0.5 |
|
||
| Interest expense |
|
(3.4 |
) |
|
(3.3 |
) |
||
| Other income |
|
0.1 |
|
|
— |
|
||
| Total other expenses |
|
(2.3 |
) |
|
(2.8 |
) |
||
| Net (loss) income before income taxes |
|
(4.6 |
) |
|
1.6 |
|
||
| Income tax expense |
|
(0.2 |
) |
|
(0.2 |
) |
||
| Net (loss) income | $ |
(4.8 |
) |
$ |
1.4 |
|
||
| Net (loss) income per share of common stock—basic | $ |
(0.10 |
) |
$ |
0.03 |
|
||
| Net (loss) income per share of common stock—diluted | $ |
(0.10 |
) |
$ |
0.03 |
|
||
| Weighted-average shares of common stock outstanding—basic |
|
48,189,256 |
|
|
46,636,083 |
|
||
| Weighted-average shares of common stock outstanding—diluted |
|
48,189,256 |
|
|
47,157,904 |
|
||
| PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY | ||||||
| LIQUIDITY AND CAPITAL RESOURCES | ||||||
| (in millions) | ||||||
| March 31, | December 31, | |||||
2024 |
2023 |
|||||
| (Unaudited) | ||||||
| Cash and cash equivalents | $ |
76.8 |
$ |
84.6 |
||
| Marketable securities |
|
30.4 |
|
11.4 |
||
| Working capital |
|
44.8 |
|
56.8 |
||
| Long term debt |
|
54.7 |
|
65.7 |
||
| Stockholders' equity |
|
51.0 |
|
53.4 |
||
| Three Months | Three Months | |||||||
| Ended | Ended | |||||||
| March 31, | March 31, | |||||||
2024 |
2023 |
|||||||
| (Unaudited) | (Unaudited) | |||||||
| Cash provided by (used in): | ||||||||
| Operating activities | $ |
11.3 |
|
$ |
2.6 |
|
||
| Investing activities |
|
(19.1 |
) |
|
(17.4 |
) |
||
| Financing activities |
|
— |
|
|
— |
|
||
| Increase (decrease) in cash and cash equivalents, and restricted cash | $ |
(7.8 |
) |
$ |
(14.8 |
) |
||
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 March 31, 2024 and 2023, stock-based compensation represented approximately
| 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 March 31, | |||||||
2024 |
2023 |
||||||
| GAAP net (loss) income | $ |
(4.8 |
) |
$ |
1.4 |
||
| Adjustments: | |||||||
| Stock-based compensation - | |||||||
| Selling, general and administrative (1) |
|
1.5 |
|
|
2.0 |
||
| Research and development (2) |
|
0.9 |
|
|
0.8 |
||
| Non-GAAP adjusted net (loss) income | $ |
(2.4 |
) |
$ |
4.2 |
||
| GAAP net (loss) income per share—basic | $ |
(0.10 |
) |
$ |
0.03 |
||
| Adjustment to net (loss) income (as detailed above) |
|
0.05 |
|
|
0.06 |
||
| Non-GAAP adjusted basic net (loss) income per share (3) | $ |
(0.05 |
) |
$ |
0.09 |
||
| GAAP net (loss) income per share—diluted | $ |
(0.10 |
) |
$ |
0.03 |
||
| Adjustment to net (loss) income (as detailed above) |
|
0.05 |
|
|
0.06 |
||
| Non-GAAP adjusted diluted net (loss) income per share (4) | $ |
(0.05 |
) |
$ |
0.09 |
||
| (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) income per share was calculated based on 48,189,256 and 46,636,083 weighted-average shares of common stock outstanding for the three months ended March 31, 2024 and 2023, respectively. | ||||||||
| (4) Non-GAAP adjusted diluted net (loss) income per share was calculated based on 48,189,256 and 47,157,904 weighted-average shares of common stock outstanding for the years ended March 31, 2024 and 2023, respectively. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240502171454/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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