Puma Biotechnology Reports Second Quarter 2022 Financial Results
Puma Biotechnology, Inc. (NASDAQ: PBYI) reported a net income of $9.4 million for Q2 2022, an improvement from a net loss of $5.1 million in Q2 2021. Product revenue reached $51.3 million, up from $48.9 million year-over-year. However, total revenue for the first half of 2022 decreased to $105.3 million compared to $151.6 million in the same period of 2021. Operating expenses significantly reduced from $148.1 million to $94.0 million year-over-year. Cash and equivalents fell to $60.8 million from $82.1 million as of December 2021. Puma aims to enhance access to its cancer drug NERLYNX and plans to report further clinical trial data in H2 2022.
- Net income increased to $9.4 million for Q2 2022, reversing a loss from Q2 2021.
- Product revenue grew to $51.3 million for Q2 2022, compared to $48.9 million in Q2 2021.
- Significant reduction in total operating expenses, down to $94.0 million from $148.1 million year-over-year.
- Total revenue for the first six months of 2022 declined to $105.3 million from $151.6 million in the first half of 2021.
- Cash reserves decreased sharply from $82.1 million at the end of 2021 to $60.8 million by June 2022.
- Total other expenses increased to $5.2 million for the first half of 2022, compared to total income of $7.9 million in the prior year.
Product revenue, net consists entirely of sales revenue from NERLYNX®, Puma’s first commercial product. Product revenue, net in the second quarter of 2022 was
Based on accounting principles generally accepted in
Non-GAAP adjusted net income was
Net cash used in operating activities for the second quarter of 2022 was
“We are very pleased to report positive net income and earnings per share for the second quarter of 2022,” said
“As per our earlier guidance, in June we reported top line data from the randomized cohort of the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation, as well as final results from the biliary tract cohort of the Phase II SUMMIT ‘basket’ trial at the 2022 Annual Meeting of the
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 of 2022, 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
Conference Call
About
Further information about
Important Safety Information Regarding NERLYNX® (neratinib)
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX 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.
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
DRUG INTERACTIONS:
- Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 3 hours with antacids. 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.
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 1-855-816-5421.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Puma’s anticipated milestones. 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, generally, from the global COVID-19 pandemic and the risk factors disclosed in the periodic and current reports filed by Puma with the
CONSOLIDATED STATEMENTS OF OPERATIONS (in millions except share and per share data) |
|||||||||||||||
Three Months Ended
|
Six Months Ended
|
||||||||||||||
2022 |
2021 |
2022 |
2021 |
||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||
Revenues: | |||||||||||||||
Product revenue, net | $ |
51.3 |
|
$ |
48.9 |
|
$ |
92.0 |
|
$ |
94.7 |
|
|||
License revenue |
|
— |
|
|
0.2 |
|
|
— |
|
|
50.3 |
|
|||
Royalty revenue |
|
8.2 |
|
|
4.3 |
|
|
13.3 |
|
|
6.6 |
|
|||
Total revenue |
|
59.5 |
|
|
53.4 |
|
|
105.3 |
|
|
151.6 |
|
|||
Operating costs and expenses: | |||||||||||||||
Cost of sales |
|
14.9 |
|
|
12.0 |
|
|
25.8 |
|
|
41.5 |
|
|||
Selling, general and administrative |
|
20.6 |
|
|
39.4 |
|
|
41.0 |
|
|
67.7 |
|
|||
Research and development |
|
11.9 |
|
|
18.6 |
|
|
27.2 |
|
|
38.9 |
|
|||
Total operating costs and expenses |
|
47.4 |
|
|
70.0 |
|
|
94.0 |
|
|
148.1 |
|
|||
Income (loss) from operations |
|
12.1 |
|
|
(16.6 |
) |
|
11.3 |
|
|
3.5 |
|
|||
Other income (expenses): | |||||||||||||||
Interest income |
|
0.1 |
|
|
0.1 |
|
|
0.1 |
|
|
0.1 |
|
|||
Interest expense |
|
(2.7 |
) |
|
(3.6 |
) |
|
(5.3 |
) |
|
(7.0 |
) |
|||
Legal verdict (expense) credit |
|
(0.1 |
) |
|
14.9 |
|
|
(0.1 |
) |
|
14.7 |
|
|||
Other income |
|
0.1 |
|
|
0.1 |
|
|
0.1 |
|
|
0.1 |
|
|||
Total other income (expenses) |
|
(2.6 |
) |
|
11.5 |
|
|
(5.2 |
) |
|
7.9 |
|
|||
Net income (loss) before income taxes | $ |
9.5 |
|
$ |
(5.1 |
) |
$ |
6.1 |
|
$ |
11.4 |
|
|||
Income tax expense |
|
(0.1 |
) |
|
— |
|
|
(0.1 |
) |
|
(0.1 |
) |
|||
Net income (loss) | $ |
9.4 |
|
$ |
(5.1 |
) |
$ |
6.0 |
|
$ |
11.3 |
|
|||
Net income (loss) per share of common stock—basic | $ |
0.21 |
|
$ |
(0.13 |
) |
$ |
0.14 |
|
$ |
0.28 |
|
|||
Net income (loss) per share of common stock—diluted | $ |
0.21 |
|
$ |
(0.13 |
) |
$ |
0.14 |
|
$ |
0.28 |
|
|||
Weighted-average shares of common stock outstanding—basic |
|
45,058,924 |
|
|
40,479,577 |
|
|
43,641,193 |
|
|
40,370,825 |
|
|||
Weighted-average shares of common stock outstanding—diluted |
|
45,358,739 |
|
|
40,479,577 |
|
|
43,889,556 |
|
|
40,939,688 |
|
LIQUIDITY AND CAPITAL RESOURCES (in millions) |
|||||||||
(Unaudited) |
|
||||||||
Cash and cash equivalents | $ |
52.8 |
|
$ |
63.1 |
|
|||
Marketable securities |
|
8.0 |
|
|
19.0 |
|
|||
Working capital |
|
57.4 |
|
|
30.4 |
|
|||
Stockholders' equity (deficit) |
|
19.7 |
|
|
(2.4 |
) |
|||
Six Months
|
Six Months
|
||||||||
Cash provided by (used in): | |||||||||
Operating activities | $ |
(40.8 |
) |
$ |
15.6 |
|
|||
Investing activities |
|
11.0 |
|
|
(11.0 |
) |
|||
Financing activities |
|
9.8 |
|
|
— |
|
|||
Increase in cash and cash equivalents, | |||||||||
and restricted cash | $ |
(20.0 |
) |
$ |
4.6 |
|
|||
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 the Company’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
Reconciliation of GAAP Net Income (Loss) to Non-GAAP Adjusted Net Income and GAAP Net Income (Loss) Per Share to Non-GAAP Adjusted Net Income Per Share (in millions except share and per share data) (Unaudited) |
|||||||||
|
|||||||||
Three Months Ended |
|
||||||||
2022 |
2021 |
|
|||||||
GAAP net income (loss) | $ |
9.4 |
|
$ |
(5.1 |
) |
|
||
Adjustments: |
|
||||||||
Stock-based compensation - |
|
||||||||
Selling, general and administrative (1) |
|
2.1 |
|
16.7 |
|
|
|||
Research and development (2) |
|
1.1 |
|
|
1.5 |
|
|
||
Non-GAAP adjusted net income | $ |
12.6 |
|
$ |
13.1 |
|
|
||
|
|||||||||
GAAP net income (loss) per share—basic | $ |
0.21 |
|
$ |
(0.13 |
) |
|
||
Adjustment to net income (loss) (as detailed above) |
|
0.07 |
|
|
0.45 |
|
|
||
Non-GAAP adjusted basic net income per share | $ |
0.28 |
|
(3) |
$ |
0.32 |
|
(4) |
|
|
|||||||||
GAAP net income (loss) per share—diluted | $ |
0.21 |
|
$ |
(0.13 |
) |
|
||
Adjustment to net income (loss) (as detailed above) |
|
0.07 |
|
|
0.45 |
|
|
||
Non-GAAP adjusted diluted net income per share | $ |
0.28 |
|
(5) |
$ |
0.32 |
|
(6) |
|
|
|||||||||
Six Months Ended |
|
||||||||
2022 |
2021 |
|
|||||||
GAAP net income | $ |
6.0 |
|
$ |
11.3 |
|
|
||
Adjustments: |
|
||||||||
Stock-based compensation - |
|
||||||||
Selling, general and administrative (1) |
|
4.3 |
|
|
20.3 |
|
|
||
Research and development (2) |
|
2.1 |
|
|
3.8 |
|
|
||
Non-GAAP adjusted net income | $ |
12.4 |
|
$ |
35.4 |
|
|
||
|
|||||||||
GAAP net income per share—basic | $ |
0.14 |
|
$ |
0.28 |
|
|
||
Adjustment to net income (as detailed above) |
|
0.14 |
|
|
0.60 |
|
|
||
Non-GAAP adjusted basic net income per share | $ |
0.28 |
|
(3) |
$ |
0.88 |
|
(4) |
|
|
|||||||||
GAAP net income per share—diluted | $ |
0.14 |
|
$ |
0.28 |
|
|
||
Adjustment to net income (as detailed above) |
|
0.14 |
|
|
0.59 |
|
|
||
Non-GAAP adjusted diluted net income per share | $ |
0.28 |
|
(5) |
$ |
0.87 |
|
(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 45,058,924 and 43,641,193 weighted-average shares of common stock outstanding for the three and six months ended |
(4) Non-GAAP adjusted basic net income per share was calculated based on 40,479,577 and 40,370,825 weighted-average shares of common stock outstanding for the three and six months ended |
(5) Non-GAAP adjusted diluted net income per share was calculated based on 45,358,739 and 43,889,556 weighted-average shares of common stock outstanding for the three and six months ended |
(6) Non-GAAP adjusted diluted net income per share was calculated based on 40,479,577 and 40,939,688 weighted-average shares of common stock outstanding for the three and six months ended |
View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005186/en/
info@pumabiotechnology.com
ir@pumabiotechnology.com
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
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