Puma Biotechnology Reports Second Quarter Financial Results
Product revenue, net consists entirely of sales revenue from NERLYNX®, Puma’s first commercial product. Product revenue, net in the second 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 second quarter of 2023 was
“We are pleased to report both positive net income and positive cash flow for the second quarter of 2023,” said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. “In addition, we announced positive biomarker data from the randomized trial of alisertib plus paclitaxel versus paclitaxel alone in hormone receptor positive, HER2-negative breast cancer at the recent 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be helpful as we move forward with the clinical development of alisertib in this indication.”
Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) initiating a Phase II clinical trial of alisertib in small cell lung cancer (H2 2023); (ii) conducting a meeting with the FDA to discuss the clinical development and registration pathway for alisertib in hormone receptor positive, HER2-negative breast cancer (Q4 2023); and (iii) reporting data from an ongoing investigator sponsored Phase I/II trial of alisertib plus pembrolizumab for the treatment of patients with Rb-deficient head and neck squamous cell cancer (H2 2023).”
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 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
Total Other Income (Expenses)
Total other expenses were
Third Quarter and Full Year 2023 Financial Outlook
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Third Quarter 2023 |
Full Year 2023 |
Product Revenue, Net |
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Royalty Revenue |
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Net Income |
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Gross to Net Adjustment |
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Conference Call
Puma Biotechnology will host a conference call to report its second quarter 2023 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, August 3, 2023. The call may be accessed by dialing (877) 709-8150 (domestic) or (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), 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.
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 third quarter and full year 2023. 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, 2022 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 |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in millions except share and per share data) |
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Three Months Ended |
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Six Months Ended |
||||||||||||
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|
June 30, |
|
June 30, |
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
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| Revenues: | ||||||||||||||||
| Product revenue, net | $ |
51.6 |
|
$ |
51.3 |
|
$ |
98.3 |
|
$ |
92.0 |
|
||||
| License revenue |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||||
| Royalty revenue |
|
3.0 |
|
|
8.2 |
|
|
9.0 |
|
|
13.3 |
|
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| Total revenue |
|
54.6 |
|
|
59.5 |
|
|
107.3 |
|
|
105.3 |
|
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| Operating costs and expenses: | ||||||||||||||||
| Cost of sales |
|
11.9 |
|
|
14.9 |
|
|
25.1 |
|
|
25.8 |
|
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| Selling, general and administrative |
|
24.4 |
|
|
20.6 |
|
|
46.8 |
|
|
41.0 |
|
||||
| Research and development |
|
13.4 |
|
|
11.9 |
|
|
26.1 |
|
|
27.2 |
|
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| Total operating costs and expenses |
|
49.7 |
|
|
47.4 |
|
|
98.0 |
|
|
94.0 |
|
||||
| Income from operations |
|
4.9 |
|
|
12.1 |
|
|
9.3 |
|
|
11.3 |
|
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| Other income (expenses): | ||||||||||||||||
| Interest income |
|
0.7 |
|
|
0.1 |
|
|
1.2 |
|
|
0.1 |
|
||||
| Interest expense |
|
(3.4 |
) |
|
(2.7 |
) |
|
(6.6 |
) |
|
(5.3 |
) |
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| Legal verdict expense |
|
— |
|
|
(0.1 |
) |
|
— |
|
|
(0.1 |
) |
||||
| Other income |
|
0.1 |
|
|
0.1 |
|
|
— |
|
|
0.1 |
|
||||
| Total other expenses, net |
|
(2.6 |
) |
|
(2.6 |
) |
|
(5.4 |
) |
|
(5.2 |
) |
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| Net income before income taxes | $ |
2.3 |
|
$ |
9.5 |
|
$ |
3.9 |
|
$ |
6.1 |
|
||||
| Income tax expense |
|
(0.2 |
) |
|
(0.1 |
) |
|
(0.4 |
) |
|
(0.1 |
) |
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| Net income | $ |
2.1 |
|
$ |
9.4 |
|
$ |
3.5 |
|
$ |
6.0 |
|
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| Net income per share of common stock—basic | $ |
0.05 |
|
$ |
0.21 |
|
$ |
0.08 |
|
$ |
0.14 |
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| Net income per share of common stock—diluted | $ |
0.05 |
|
$ |
0.21 |
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$ |
0.07 |
|
$ |
0.14 |
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| Weighted-average shares of common stock outstanding—basic |
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46,759,062 |
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45,058,924 |
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46,697,912 |
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43,641,193 |
|
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| Weighted-average shares of common stock outstanding—diluted |
|
47,201,185 |
|
|
45,358,739 |
|
|
47,172,752 |
|
|
43,889,556 |
|
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| PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY | ||||||||
| LIQUIDITY AND CAPITAL RESOURCES | ||||||||
| (in millions) | ||||||||
June 30, |
|
December 31, |
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2023 |
|
2022 |
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(Unaudited) |
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| Cash and cash equivalents | $ |
60.0 |
|
$ |
76.2 |
|
||
| Marketable securities |
|
14.4 |
|
|
4.9 |
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| Working capital |
|
58.5 |
|
|
56.8 |
|
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| Short term debt |
|
11.3 |
|
|
— |
|
||
| Long term debt |
|
87.6 |
|
|
98.3 |
|
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| Stockholders' equity |
|
30.4 |
|
|
21.6 |
|
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Six Months |
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Six Months |
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Ended |
|
Ended |
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June 30, |
|
June 30, |
||||||
2023 |
|
2022 |
||||||
(Unaudited) |
|
(Unaudited) |
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| Cash provided by (used in): | ||||||||
| Operating activities | $ |
5.9 |
|
$ |
(40.7 |
) |
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| Investing activities |
|
(22.1 |
) |
|
11.0 |
|
||
| Financing activities |
|
— |
|
|
9.8 |
|
||
| Decrease in cash and cash equivalents, and restricted cash | $ |
(16.2 |
) |
$ |
(19.9 |
) |
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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 and net income 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, 2023, stock-based compensation represented approximately
| PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY | ||||||||||
| Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income and | ||||||||||
GAAP Net Income Per Share to Non-GAAP Adjusted Net Income Per Share |
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(in millions except share and per share data) |
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(Unaudited) |
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Three Months Ended June 30, |
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|
2023 |
|
2022 |
|
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| GAAP net income | $ |
2.1 |
$ |
9.4 |
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| Adjustments: | ||||||||||
| Stock-based compensation - | ||||||||||
| Selling, general and administrative (1) |
|
1.8 |
|
2.1 |
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| Research and development (2) |
|
0.8 |
|
1.1 |
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| Non-GAAP adjusted net income | $ |
4.6 |
$ |
12.6 |
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| GAAP net income per share—basic | $ |
0.05 |
$ |
0.21 |
||||||
| Adjustment to net income (as detailed above) |
|
0.05 |
|
0.07 |
||||||
| Non-GAAP adjusted basic net income per share | $ |
0.10 |
(3 |
) |
$ |
0.28 |
(4 |
) |
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| GAAP net income per share—diluted | $ |
0.05 |
$ |
0.21 |
||||||
| Adjustment to net income (as detailed above) |
|
0.05 |
|
0.07 |
||||||
| Non-GAAP adjusted diluted net income per share | $ |
0.10 |
(5 |
) |
$ |
0.28 |
(6 |
) |
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Six Months Ended June 30, |
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2023 |
|
2022 |
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| GAAP net income | $ |
3.5 |
$ |
6.0 |
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| Adjustments: | ||||||||||
| Stock-based compensation - | ||||||||||
| Selling, general and administrative (1) |
|
3.7 |
|
4.2 |
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| Research and development (2) |
|
1.6 |
|
2.1 |
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| Non-GAAP adjusted net income | $ |
8.8 |
$ |
12.3 |
||||||
| GAAP net income per share—basic | $ |
0.08 |
$ |
0.14 |
||||||
| Adjustment to net income (as detailed above) |
|
0.11 |
|
0.14 |
||||||
| Non-GAAP adjusted basic net income per share | $ |
0.19 |
(3 |
) |
$ |
0.28 |
(4 |
) |
||
| GAAP net income per share—diluted | $ |
0.07 |
$ |
0.14 |
||||||
| Adjustment to net income (as detailed above) |
|
0.12 |
|
0.14 |
||||||
| Non-GAAP adjusted diluted net income per share | $ |
0.19 |
(5 |
) |
$ |
0.28 |
(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 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. | ||||||||
| (4) 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 June 30, 2022, respectively. | ||||||||
| (5) 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. | ||||||||
| (6) 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 June 30, 2022, respectively. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230803523303/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.
