Puma Biotechnology Reports Third Quarter 2021 Financial Results
Puma Biotechnology, Inc. (PBYI) reported a net loss of $44.7 million, or $1.09 per share, for Q3 2021, compared to a net loss of $31.5 million, or $0.79 per share, in Q3 2020. Product revenue fell to $43.4 million from $49.3 million year-over-year. Total revenue for Q3 2021 was $46.2 million, down from $50.8 million in Q3 2020. Despite challenges from COVID-19, the company noted a positive uptake in its product NERLYNX due to recent label expansions. Cash and marketable securities totaled $87.5 million as of September 30, 2021, down from $93.4 million at year-end 2020.
- Increase in net cash provided by operating activities to $10.5 million in Q3 2021, up from $1.7 million in Q3 2020.
- Successful label expansion for NERLYNX leading to improved uptake.
- Recent regulatory approval for NERLYNX in South Korea.
- Decline in product revenue to $43.4 million in Q3 2021 from $49.3 million in Q3 2020.
- Net loss increased to $44.7 million in Q3 2021 from $31.5 million in Q3 2020.
- Total other expenses rose significantly to $35.7 million in Q3 2021 from $19.4 million in Q3 2020.
Product revenue, net consists entirely of sales revenue from NERLYNX®, Puma’s first commercial product. Product revenue, net for the third quarter of 2021 was
Based on accounting principles generally accepted in
Non-GAAP adjusted net loss was
Net cash provided by operating activities for the third quarter of 2021 was
“Our operating results continued to be negatively impacted by the effects of COVID-19 and its limitations to our access to healthcare providers during the third quarter,” said
Revenue
Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the third quarter of 2021, 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
The
The
Research and Development Expenses
Research and development (R&D) expenses were
The
Total Other 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 dose escalation or loperamide, treat with loperamide, 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 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 and the outcome of its class action lawsuit. 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, anticipated obligations arising from the conclusion of the class action lawsuit, 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 |
|
Nine Months Ended |
||||||||||||||
|
|
|
|
|
||||||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ |
43.4 |
|
$ |
49.3 |
|
$ |
138.1 |
|
$ |
146.7 |
|
||||
| License revenue |
|
— |
|
|
— |
|
|
50.3 |
|
|
22.7 |
|
||||
| Royalty revenue |
|
2.8 |
|
|
1.5 |
|
|
9.4 |
|
|
3.2 |
|
||||
| Total revenue |
|
46.2 |
|
|
50.8 |
|
|
197.8 |
|
|
172.6 |
|
||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of sales |
|
10.3 |
|
|
10.0 |
|
|
51.8 |
|
|
28.4 |
|
||||
| Selling, general and administrative |
|
26.1 |
|
|
29.6 |
|
|
93.8 |
|
|
89.9 |
|
||||
| Research and development |
|
18.8 |
|
|
23.3 |
|
|
57.7 |
|
|
73.5 |
|
||||
| Total operating costs and expenses |
|
55.2 |
|
|
62.9 |
|
|
203.3 |
|
|
191.8 |
|
||||
| Loss from operations |
|
(9.0 |
) |
|
(12.1 |
) |
|
(5.5 |
) |
|
(19.2 |
) |
||||
| Other income (expenses): | ||||||||||||||||
| Interest income |
|
— |
|
|
— |
|
|
0.1 |
|
|
0.5 |
|
||||
| Interest expense |
|
(3.1 |
) |
|
(3.6 |
) |
|
(10.1 |
) |
|
(10.5 |
) |
||||
| Legal verdict expense |
|
(24.5 |
) |
|
(15.9 |
) |
|
(9.8 |
) |
|
(16.0 |
) |
||||
| Loss on debt extinguishment |
|
(8.1 |
) |
|
— |
|
|
(8.1 |
) |
|
— |
|
||||
| Other income |
|
— |
|
|
0.1 |
|
|
0.2 |
|
|
0.2 |
|
||||
| Total other expenses |
|
(35.7 |
) |
|
(19.4 |
) |
|
(27.7 |
) |
|
(25.8 |
) |
||||
| Net loss before income taxes | $ |
(44.7 |
) |
$ |
(31.5 |
) |
$ |
(33.2 |
) |
$ |
(45.0 |
) |
||||
| Income tax expense |
|
— |
|
|
— |
|
|
(0.2 |
) |
|
— |
|
||||
| Net loss | $ |
(44.7 |
) |
$ |
(31.5 |
) |
$ |
(33.4 |
) |
$ |
(45.0 |
) |
||||
| Net loss per share of common stock—basic | $ |
(1.09 |
) |
$ |
(0.79 |
) |
$ |
(0.82 |
) |
$ |
(1.14 |
) |
||||
| Net loss per share of common stock—diluted | $ |
(1.09 |
) |
$ |
(0.79 |
) |
$ |
(0.82 |
) |
$ |
(1.14 |
) |
||||
| Weighted-average shares of common stock outstanding—basic |
|
40,813,609 |
|
|
39,695,444 |
|
|
40,520,041 |
|
|
39,473,691 |
|
||||
| Weighted-average shares of common stock outstanding—diluted |
|
40,813,609 |
|
|
39,695,444 |
|
|
40,520,041 |
|
|
39,473,691 |
|
||||
| LIQUIDITY AND CAPITAL RESOURCES | ||||||||||||||||
| (in millions) | ||||||||||||||||
|
|
|
|
|
|
|
||||||||||
|
|
2021 |
|
2020 |
||||||||||||
| (Unaudited) | ||||||||||||||||
| Cash and cash equivalents | $ |
63.9 |
|
$ |
85.3 |
|
||||||||||
| Marketable securities |
|
23.6 |
|
|
8.1 |
|
||||||||||
| Working capital |
|
20.7 |
|
|
31.9 |
|
||||||||||
| Stockholders' deficit |
|
(10.9 |
) |
|
(6.0 |
) |
||||||||||
|
|
Nine Months
|
|
Nine Months
|
|
|
|
|
||||||||
|
|
(Unaudited) |
|
(Unaudited) |
||||||||||||
| Cash provided by (used in): | ||||||||||||||||
| Operating activities | $ |
26.1 |
|
$ |
6.4 |
|
||||||||||
| Investing activities |
|
(15.5 |
) |
|
22.6 |
|
||||||||||
| Financing activities |
|
(31.9 |
) |
|
— |
|
||||||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | $ |
(21.3 |
) |
$ |
29.0 |
|
||||||||||
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 loss and net loss per share calculated in accordance with GAAP and as adjusted to remove the impact of stock-based compensation. For the three months and nine months ended
| Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss and | ||||||||
| GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per Share | ||||||||
| (in millions except share and per share data) | ||||||||
| (Unaudited) | ||||||||
Three Months Ended |
||||||||
2021 |
2020 |
|||||||
| GAAP net loss | $ |
(44.7 |
) |
$ |
(31.5 |
) |
||
| Adjustments: | ||||||||
| Stock-based compensation - | ||||||||
| Selling, general and administrative (1) |
|
3.0 |
|
|
4.1 |
|
||
| Research and development (2) |
|
1.3 |
|
|
3.5 |
|
||
| Non-GAAP adjusted net loss | $ |
(40.4 |
) |
$ |
(23.9 |
) |
||
| GAAP net loss per share—basic | $ |
(1.09 |
) |
$ |
(0.79 |
) |
||
| Adjustment to net loss (as detailed above) |
|
0.10 |
|
|
0.19 |
|
||
| Non-GAAP adjusted basic net loss per share (3) (4) | $ |
(0.99 |
) |
$ |
(0.60 |
) |
||
| GAAP net loss per share—diluted | $ |
(1.09 |
) |
$ |
(0.79 |
) |
||
| Adjustment to net loss (as detailed above) |
|
0.10 |
|
|
0.19 |
|
||
| Non-GAAP adjusted diluted net loss per share (5) (6) | $ |
(0.99 |
) |
$ |
(0.60 |
) |
||
| Nine Months Ended |
||||||||
2021 |
2020 |
|||||||
| GAAP net loss | $ |
(33.4 |
) |
$ |
(45.0 |
) |
||
| Adjustments: | ||||||||
| Stock-based compensation - | ||||||||
| Selling, general and administrative (1) |
|
23.3 |
|
|
13.5 |
|
||
| Research and development (2) |
|
5.1 |
|
|
13.6 |
|
||
| Non-GAAP adjusted net loss | $ |
(5.0 |
) |
$ |
(17.9 |
) |
||
| GAAP net loss per share—basic | $ |
(0.82 |
) |
$ |
(1.14 |
) |
||
| Adjustment to net loss (as detailed above) |
|
0.70 |
|
|
0.69 |
|
||
| Non-GAAP adjusted basic net loss per share (3) (4) | $ |
(0.12 |
) |
$ |
(0.45 |
) |
||
| GAAP net loss per share—diluted | $ |
(0.82 |
) |
$ |
(1.14 |
) |
||
| Adjustment to net loss (as detailed above) |
|
0.70 |
|
|
0.69 |
|
||
| Non-GAAP adjusted diluted net loss per share (5) (6) | $ |
(0.12 |
) |
$ |
(0.45 |
) |
||
(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 per share was calculated based on 40,813,609 and 40,520,041 weighted-average shares of common stock outstanding for the three and nine months ended |
|||||
(4) |
Non-GAAP adjusted basic net loss per share was calculated based on 39,695,444 and 39,473,691 weighted-average shares of common stock outstanding for the three and nine months ended |
|||||
(5) |
Non-GAAP adjusted diluted net loss per share was calculated based on 40,813,609 and 40,520,041 weighted-average shares of common stock outstanding for the three and nine months ended |
|||||
(6) |
Non-GAAP adjusted diluted net loss per share was calculated based on 39,695,444 and 39,473,691 weighted-average shares of common stock outstanding for the three and nine months ended |
|||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20211104005461/en/
info@pumabiotechnology.com
ir@pumabiotechnology.com
david.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com
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