PBYI on Nasdaq

Puma Biotechnology

American biopharmaceutical company

Puma Biotechnology is a publicly traded biopharmaceutical company (NASDAQ: PBYI) headquartered in Los Angeles, CA.3 Wikipedia text CC BY-SA 4.0

$10.68 up 0.48 (4.71%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

Compare with ANAPTYSBIO, INC, Akebia Therapeutics, Inc. or Ideaya Biosciences (United States), or pick any stock.

  • TickerPBYI on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersLos Angeles1
  • Websitewww.pumabiotechnology.com
  • Incorporated inDE5
  • Business address10880 Wilshire Blvd., Suite 1700, Los Angeles, Ca5
  • Filer categoryAccelerated filer, Smaller reporting company5

Puma Biotechnology is a publicly traded biopharmaceutical company (NASDAQ: PBYI) headquartered in Los Angeles, CA.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

16.3%Operating margin8
13.6%Net margin8
-0.9%Revenue growth, 20258
23.9%Return on equity8
0.00×Debt to equity8
$41.7MFree cash flow8

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 89% of the revenue Puma Biotechnology broke down this way in fiscal 2025.

  1. Product$204.1M889%up 5% from 2024
  2. Royalty$24.3M811%down 31% from 2024
Products and services by year
Products and services2022202320242025
Product$203.1M$195.2M$204.1M
Royalty$32.5M$35.3M$24.3M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue25¢$58.2M
  • Selling, general and admin31¢$70.8M
  • Other costs28¢$63.6M
  • Income tax2¢$4.7M
  • Profit14¢$31.1M

Out of $228.4M in revenue.8

Where each dollar of operating cash went, fiscal 2025

  • Capital spending0¢$71.0K
  • Kept or used elsewhere100¢$41.7M

Out of $41.8M of cash from operations.8

Financial statements

Revenue91011128$228.4M in 2025−16% since 2019
0$100.0M$200.0M$300.0M2019: $272.3M$272.3M20192020: $225.1M$225.1M2020−17%2021: $253.2M$253.2M2021+12%2022: $228.0M$228.0M2022−10%2023: $235.6M$235.6M2023+3%2024: $230.5M$230.5M2024−2%2025: $228.4M$228.4M2025−1%
Operating income91011128$37.3M in 2025
-$40.0M-$20.0M0$20.0M$40.0M2019: -$39.0M-$39.0M20192020: -$30.4M-$30.4M2020−22%2021: $1.3M$1.3M20212022: $23.7M$23.7M2022+1739%2023: $32.6M$32.6M2023+38%2024: $31.0M$31.0M2024−5%2025: $37.3M$37.3M2025+20%
Net income91011128$31.1M in 2025
-$100.0M-$50.0M0$50.0M2019: -$75.6M-$75.6M20192020: -$60.0M-$60.0M2020−21%2021: -$29.1M-$29.1M2021−51%2022: $2.0K$2.0K20222023: $21.6M$21.6M2023+1079450%2024: $30.3M$30.3M2024+40%2025: $31.1M$31.1M2025+3%

Every line of the income statement as filed: the last 3 fiscal years, latest first.8

Period ending2025-12-312024-12-312023-12-31
Total revenue$228.4M$230.5M$235.6M
Cost of sales$58.2M$64.4M$62.7M
Selling, general and administrative$70.8M$80.2M$89.9M
Research and development$62.1M$54.9M$50.4M
Total operating costs and expenses$191.1M$199.5M$203.0M
Income from operations$37.3M$31.0M$32.6M
Interest income$4.1M$4.7M$2.6M
Interest expense-$6.6M-$12.5M-$13.3M
Other income$1.0M$862.0K$759.0K
Total other expenses, net-$1.5M-$6.9M-$10.0M
Income Before Income Taxes$35.8M$24.1M$22.7M
Current income tax (expense)-$1.4M-$897.0K-$1.1M
Deferred income tax (expense) benefit-$3.2M$7.1M$0
Net income$31.1M$30.3M$21.6M
Net income per share of common stockbasic (in dollars per share)$0.62$0.62$0.46
Net income per share of common stockdiluted (in dollars per share)$0.61$0.62$0.45
Weighted-average shares of common stock outstandingbasic (in shares)50.0M shares48.6M shares47.1M shares
Weighted-average shares of common stock outstandingdiluted (in shares)50.7M shares49.1M shares47.6M shares

Compare Puma Biotechnology with another company

Corporate structure

Puma Biotechnology sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Puma Biotechnology

  • Puma Biotechnology Los Angeles

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Puma Biotechnology reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$4.8M8 Dec 31, 2025$8.4M8 Dec 31, 2024−42.9%
Accumulated depreciation$4.6M8 Dec 31, 2025$7.9M8 Dec 31, 2024−41.6%
Property and equipment, net$187.0K8 Dec 31, 2025$515.0K8 Dec 31, 2024−63.7%
Operating-lease assets (leased space)$5.4M8 Dec 31, 2025$4.6M8 Dec 31, 2024+17.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$29.6M8 Dec 31, 2025$69.2M8 Dec 31, 2024−57.2%
Marketable securities, current$67.9M8 Dec 31, 2025$31.7M8 Dec 31, 2024+113.9%

Intangibles and goodwill

ItemLatestA year beforeChange
Accumulated amortization$61.1M8 Dec 31, 2025$51.4M8 Dec 31, 2024+19.0%
Finite-lived intangibles, net$41.4M8 Dec 31, 2025$51.1M12 Dec 31, 2024−19.0%
Licenses, net$102.5M8 Dec 31, 2025$102.5M8 Dec 31, 20240%

Inventory

ItemLatestA year beforeChange
Inventory, total$5.5M8 Dec 31, 2025$8.7M8 Dec 31, 2024−36.8%
Raw materials$3.2M8 Dec 31, 2025$7.2M8 Dec 31, 2024−55.3%
Work in process$1.3M8 Dec 31, 2025$758.0K8 Dec 31, 2024+77.2%
Finished goods$960.0K8 Dec 31, 2025$783.0K8 Dec 31, 2024+22.6%

Properties, in its own words

We lease approximately 65,656 square feet of office space in the building located at 10880 Wilshire Boulevard, Los Angeles, California for use as our corporate headquarters. This lease commenced in December 2011 and over time has been amended to add rentable square footage. In February 2019, we entered into a long-term sublease agreement whereby we sublease 12,429 square feet of this office space to a third party subtenant. This sublease was terminated in December 2024. Also, in August 2023, we entered into a long-term sublease agreement whereby we sublease 13,916 square feet of this office space to a third party subtenant. The rental amounts payable to us pursuant to both subleases increase approximately 3% and terminate in March 2026. In July 2025, we executed an amendment to our office space in Los Angeles, California to surrender certain suites effective March 31, 2026 and extend the lease term for the remaining 26,700 rentable square feet in suite 17 for an additional five years and five months through August 31, 2031. We also lease approximately 29,470 square feet of office space in the building located at 701 Gateway Blvd, South San Francisco, California. The lease for the South San Francisco facility commenced in October 2012. The South San Francisco lease will terminate around March 2026. We believe that our office space in Los Angeles is adequate to meet current and anticipated future requirements and that additional or substitute space will be available as needed to accommodate any expansions that our operations require.

Item 2 of the 10-K filed Feb 26, 2026.16

The story

Puma was founded in September 2010 by Alan Auerbach to identify and in-license compounds that were already in clinical development. This was the same business plan Auerbach had followed at Cougar Biotechnology, which he founded in 2003, and through which he in-licensed abiraterone acetate from BTG plc. Cougar further developed abiraterone before the company was sold to Johnson & Johnson in 2009. Auerbach brought many Cougar employees with him after founding Puma in 2010.

From Wikipedia’s article on Puma Biotechnology, shared under CC BY-SA 4.0.6

Leadership

Who has led Puma Biotechnology, and when. Pick a name to see everywhere that person has worked.

Chief financial officer

  1. Maximo F. Nougues2018–now
2010201520202025
Board members and other officers (21)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Puma Biotechnology B.V. Netherlands7

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • INNOVATIVE ACQUISITIONS CORPSep 14, 2007 to Oct 4, 20115

Timeline

  1. Aug 6, 20268-K Results of operations38
  2. Jun 16, 20268-K Shareholder vote39
  3. May 7, 20268-K Results of operations40
  4. Feb 26, 20268-K Results of operations41
  5. Nov 6, 20258-K Results of operations42
  6. Aug 7, 20258-K Results of operations43
  7. Jun 24, 20258-K Bylaws or fiscal year changed44
  8. Jun 13, 20258-K Shareholder vote45
  9. May 9, 20258-K Executive or director change46
  10. May 8, 20258-K Results of operations47
  11. Feb 27, 20258-K Results of operations48
  12. Nov 7, 20248-K Results of operations49
  13. Oct 11, 2011New chief executive Alan H. Auerbach becomes CEO17

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.17 a share, on Nov 6, 2025.50

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results38
  2. May 7, 2026Reported quarterly or annual results40
  3. Feb 26, 2026Reported quarterly or annual results41
  4. Nov 6, 2025Reported quarterly or annual results42
  5. Aug 7, 2025Reported quarterly or annual results43
  6. May 8, 2025Reported quarterly or annual results47
  7. Feb 27, 2025Reported quarterly or annual results48
  8. Nov 7, 2024Reported quarterly or annual results49

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

364 filings to the SEC since October 2021: 5 annual reports, 16 quarterly reports, 48 major events, 173 insider forms, 32 large holders, 90 other. The latest 20:

  1. Oct 6, 2026SCHEDULE 13D/A EDGAR
  2. Sep 16, 20264 EDGAR
  3. Sep 16, 20264 EDGAR
  4. Sep 14, 2026144 EDGAR
  5. Sep 14, 2026144 EDGAR
  6. Aug 6, 202610-Q EDGAR
  7. Aug 6, 20268-K EDGAR
  8. Jul 8, 20264 EDGAR
  9. Jul 8, 20264 EDGAR
  10. Jul 8, 20264 EDGAR
  11. Jul 6, 2026144 EDGAR
  12. Jul 6, 2026144 EDGAR
  13. Jul 6, 2026144 EDGAR
  14. Jun 16, 20268-K EDGAR
  15. Jun 15, 20264 EDGAR
  16. Jun 15, 20264 EDGAR
  17. Jun 15, 20264 EDGAR
  18. Jun 15, 20264 EDGAR
  19. Jun 15, 20264 EDGAR
  20. Jun 15, 20264 EDGAR

The 364 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

130 open-market trades by officers, directors and large owners since October 2021: 0 buys and 130 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 14, 2026WILSON TROY EDWARDDirectorSale5,000$9.10$45.5KForm 4
Sep 14, 2026Cesano AlessandraDirectorSale62,150$9.12$566.8KForm 4
Jul 6, 2026AUERBACH ALAN HPresident and CEOSale44,058$8.26$363.9KForm 4
Jul 6, 2026HUNT DOUGLAS MSee RemarksSale8,460$8.26$69.9KForm 4
Jul 6, 2026NOUGUES MAXIMO FChief Financial OfficerSale9,386$8.26$77.5KForm 4
Jun 12, 2026WILSON TROY EDWARDDirectorSale10,800$7.20$77.8KForm 4
Jun 12, 2026Stuglik Brian MDirectorSale8,100$7.20$58.3KForm 4
Jun 12, 2026Senderowicz AdrianDirectorSale27,000$7.20$194.4KForm 4
Jun 12, 2026MOYES JAY MDirectorSale22,000$7.22$158.8KForm 4
Jun 12, 2026Dorval AllisonDirectorSale11,610$7.20$83.6KForm 4
Jan 7, 2026AUERBACH ALAN HPresident and CEOSale18,012$5.88$105.9KForm 4
Jan 7, 2026HUNT DOUGLAS MSee RemarksSale5,014$5.88$29.5KForm 4
Jan 7, 2026NOUGUES MAXIMO FChief Financial OfficerSale6,405$5.88$37.7KForm 4
Jan 6, 2026AUERBACH ALAN HPresident and CEOSale16,938$5.84$98.9KForm 4
Jan 6, 2026HUNT DOUGLAS MSee RemarksSale3,973$5.84$23.2KForm 4
Jan 6, 2026NOUGUES MAXIMO FChief Financial OfficerSale4,540$5.84$26.5KForm 4
Nov 11, 2025MILLER MICHAEL PATRICKDirectorSale20,000$4.86$97.2KForm 4
Jul 18, 2025Cesano AlessandraDirectorSale27,000$3.37$91.0KForm 4
Jul 9, 2025NOUGUES MAXIMO FChief Financial OfficerSale3,935$3.54$13.9KForm 4
Jul 9, 2025HUNT DOUGLAS MSee RemarksSale3,443$3.54$12.2KForm 4

All 130 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Alan H. Auerbach56$931.3K$3.1M63
2025Jeff J. Ludwig$264.9K$1.5M63
2025Maximo F. Nougues57$563.0K$1.2M63
2025Douglas HuntB.Sc. (Hons)$489.1K$1.1M63
2024President and Chief Executive Officer$904.2K$4.0M63
2024Chief Financial Officer$538.7K$1.4M63
2024Chief Commercial Officer$608.5K$1.2M63
2024Chief Regulatory AffairsMedical Affairs,$461.9K$1.2M63
2023President and Chief Executive Officer$877.9K$2.9M63
2023Chief Commercial Officer$596.6K$1.4M63
2023Chief Financial Officer$515.5K$1.2M63
2023and Pharmacovigilance Officer$428.0K$1.0M63

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Acorn Capital Advisors, LLC4,131,299$33.5M9.1%No change
BlackRock, Inc.3,804,736$30.9M0.0%+205,784
American Century Companies Inc2,319,996$18.8M0.0%+403,650
Renaissance Technologies LLC1,836,213$14.9M0.0%−106,200
Vanguard Capital Management LLC1,835,643$14.9M0.0%+17,962
Vanguard Portfolio Management LLC1,825,599$14.8M0.0%+90,950
Dimensional Fund Advisors LP1,518,014$12.3M0.0%+81,908
Geode Capital Management, LLC1,339,405$10.9M0.0%+322,063
O'shaughnessy Asset Management, LLC1,123,783$9.1M0.0%−14,386
State Street Corp952,165$7.7M0.0%+34,575
Kennedy Capital Management LLC873,253$7.1M0.1%−16,348
Bridgeway Capital Management, LLC791,616$6.4M0.1%+16,275
Ritholtz Wealth Management749,798$6.1M0.1%−24,510
Aqr Capital Management LLC725,192$5.9M0.0%−75,002
Goldman Sachs Group Inc669,156$5.4M0.0%−563
Northern Trust Corp652,386$5.3M0.0%+10,633
Connor, Clark & Lunn Investment Management Ltd.642,946$5.2M0.0%−139,852
UBS Group AG636,761$5.2M0.0%+102,534
Millennium Management LLC602,240$4.9M0.0%−875,279
Arrowstreet Capital, Limited Partnership532,450$4.3M0.0%−5,705
Sei Investments Co418,669$3.4M0.0%−89,513
Globeflex Capital L P382,807$3.1M0.4%+33,156
Bank of New York Mellon Corp360,734$2.9M0.0%+12,853
D. E. Shaw & Co., Inc.316,343$2.6M0.0%−34,892
State Board Of Administration Of Florida Retirement System309,106$2.5M0.0%+36,216

13F reports cover disclosed long positions in U.S. stocks only.

Members of Congress who traded it

2 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
May 15, 2019Donna Shalala, HouseSale$1,001 - $15,000+207.3%Report
Jan 23, 2019Donna Shalala, HouseBuy$1,001 - $15,000−250.2%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Puma Biotechnology is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARPUMA BIOTECHNOLOGY, INC.2
  • CIK0001401667
  • Employer ID (EIN)77-068348716
  • Filer statusAccelerated filer not an emerging growth company; a smaller reporting company; not a shell company16
  • Incorporated inDelaware16
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address10880 Wilshire Blvd., Suite 1700, Los Angeles, CA2
  • Phone(424) 248-65002
  • Shares outstanding51,620,066 as of Aug 3, 202614
  • Public float$145.2M as of Jun 30, 202516
  • AuditorKPMG LLP, Los Angeles, CA PCAOB ID 185; it also attests to the company’s internal control over financial reporting16
  • On EDGAR sinceSep 14, 20072
  • Filings1,122 in all: 4 (437), 8-K (205), SC 13G/A (71), 144 (67), 10-Q (56), SC 13G (37), 3 (26), DEFA14A (24)2
    All 57 form types

    10-K (18), UPLOAD (18), DEF 14A (15), CORRESP (14), 424B3 (10), 4/A (8), CT ORDER (8), S-8 (8), SC 13D/A (8), ARS (7), DFAN14A (7), EFFECT (7), SCHEDULE 13G/A (7), 424B1 (4), 424B5 (4), S-1/A (4), SC 13D (4), 8-K/A (3), PRE 14A (3), PRER14A (3), S-3 (3), 8-A12B (2), D (2), DEFC14A (2), DEFR14A (2), POS AM (2), PREC14A (2), PRRN14A (2), S-1 (2), 10-Q/A (1), 10KSB (1), 10QSB (1), 10SB12G (1), 144/A (1), 25 (1), 424B2 (1), CERTNAS (1), CERTNYS (1), D/A (1), DEF 14C (1), FWP (1), NT 10-K (1), PRE 14C (1), S-1MEF (1), S-3/A (1), S-3ASR (1), S-3MEF (1), SC 14F1 (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per sharePBYINASDAQ

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks Puma Biotechnology names in Item 1A of its 10-K filed Feb 26, 2026: 57 risks under these headings, as written.16

  • In addition to the other information contained in this Annual Report, the following risk factors should be considered carefully in evaluating our company. Our business, financial condition, liquidity and results of operations could be materially adversely affected by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us.
  • Risks Related to our Financial Condition and Capital Requirements
  • While we have reported net income in recent years, we cannot assure that we will continue to do so and may not be able to maintain profitability.
  • We are currently a single product company with limited commercial sales experience.
  • We may not be able to successfully commercialize NERLYNX in the future.
  • We may not be able to secure additional financing on favorable terms, or at all, to meet our future capital needs and our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development or commercialization efforts or other operations.
  • The terms of our Note Purchase Agreement place restrictions on our ability to operate our business and on our financial flexibility, and we may be unable to achieve the revenue necessary for us to incur additional borrowings under the Note Purchase Agreement or to satisfy the minimum revenue and cash balance covenants.
  • Risks Related to the Discovery and Development of our Products and Drug Candidates
  • We have in-licensed alisertib, a drug candidate for which we have assumed all responsibility for global development and commercialization. Our development of alisertib will be expensive, lengthy and unpredictable, and any failure to successfully develop alisertib will have a material adverse effect on our business and financial position.
  • Interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • NERLYNX, alisertib or other drug candidates may cause undesirable side effects or have other properties when used alone or in combination with other approved products or investigational new drugs that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any, as applicable.
  • We are in the early stages of development of alisertib, and we cannot be certain that we will be successful if we seek regulatory approvals for our drug candidates.
The other 47 risks
  • We are subject to ongoing obligations and continued regulatory review with regard to NERLYNX, alisertib and any other drug candidates that may receive FDA or foreign regulatory approval, which may result in significant expense. Additionally, NERLYNX, alisertib and our other drug candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations or policy changes could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Clinical trials are very expensive, time-consuming and difficult to design and implement.
  • Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • The results of our clinical trials may not support our drug candidate claims.
  • Risks Related to Commercialization of our Drug Candidates
  • We have limited experience as a company in marketing or distributing pharmaceutical products. If we are unable to expand our marketing and sales capabilities in the commercialization of NERLYNX, our business, results of operations and financial condition may be materially adversely affected.
  • We are exposed to the risks associated with reliance on a direct sales force to commercialize NERLYNX in the United States.
  • Our NERLYNX commercialization efforts may fail to achieve the degree of market acceptance by patients and physicians necessary for commercial success.
  • We depend on a limited number of customers for a significant amount of our total revenue, and if we lose any of our significant customers, our business could be harmed.
  • Outside the United States we rely primarily on third-parties to pursue regulatory approval, if necessary, and to commercialize NERLYNX and they may not commit sufficient time or resources to marketing NERLYNX.
  • Even though the FDA and EC have granted approval of NERLYNX for the extended adjuvant treatment of certain patients with early stage, HER2-positive breast cancer and the FDA has granted approval for NERLYNX for the treatment of certain patients with metastatic HER2-positive breast cancer, the terms of the approvals may limit its commercial potential.
  • Regulatory approval for any approved product is limited by the FDA and foreign regulatory authorities to those specific indications and conditions for which clinical safety and efficacy have been demonstrated as set forth on the product label. If we market our products for uses beyond such approved indications, we could be subject to enforcement action, which could have a material adverse effect on our business.
  • We may fail to obtain orphan drug designations from the FDA for our drug candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • Health care reform measures may hinder or prevent our products’ and drug candidates’ commercial success.
  • Failure to obtain or maintain adequate coverage and reimbursement for our products or drug candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • We are subject to federal, state and foreign healthcare fraud and abuse laws, false claims laws and physician payment transparency laws. Failure to comply with these laws may subject us to substantial penalties.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the United States, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, results of operations and financial condition.
  • Risks Related to Third Parties
  • We are dependent on international third-party sub-licensees for the development and commercialization of NERLYNX in several countries outside the United States. The failure of these sub-licensees to meet their contractual, regulatory or other obligations could adversely affect our business.
  • We have no experience in drug formulation or manufacturing and rely exclusively on third parties to formulate and manufacture NERLYNX, alisertib and our other drug candidates, and any disruption or loss of these relationships could delay our development and commercialization efforts.
  • If our third-party manufacturers fail to manufacture NERLYNX in sufficient quantities and at acceptable quality and pricing levels, or fail to fully comply with cGMP or similar foreign regulations, we may face delays in commercialization or be unable to meet market demand, and may lose potential revenues.
  • We rely on third parties to conduct our pre-clinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for our drug candidates.
  • Risks Related to our Business Operations
  • Engaging in international business subjects us to additional business and regulatory risks, and there can be no assurance that our products will be accepted in those markets.
  • The failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws, including the FCPA and similar laws associated with our activities outside of the United States, could subject us to penalties and other adverse consequences.
  • If we fail to comply with United States export control and economic sanctions or fail to expand and maintain an effective sales force or successfully develop our international distribution network, our business, financial condition and operating results may be adversely affected.
  • We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm us.
  • Compliance with governmental regulation and other legal obligations related to privacy, data protection and information security could result in additional costs and liabilities to us or inhibit our ability to collect and process data, and the failure to comply with such requirements could have a material adverse effect on our business, financial condition or results of operations.
  • If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenue and our business will suffer.
  • We may be exposed to liability claims associated with the use of hazardous materials and chemicals.
  • The loss of one or more key members of our management team could adversely affect our business.
  • If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed
  • We may not successfully manage our growth.
  • We may be adversely affected by the current economic environment.
  • We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits and product recalls.
  • We may in the future engage in strategic transactions that increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
  • Risks Related to our Intellectual Property
  • We depend significantly on in-licensed intellectual property, and the termination of these licenses would significantly harm our business and future prospects.
  • Our proprietary rights may not adequately protect our intellectual property and potential products, and if we cannot obtain adequate protection of our intellectual property and potential products, we may not be able to successfully market our potential products.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Our ability to commercialize our products will depend on our ability to sell such products without infringing the patent or proprietary rights of third parties. If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • Risks Related to Owning our Common Stock
  • The price of our common stock could be subject to volatility related or unrelated to our operations.
  • We have been subject to securities litigation in the past, and volatility in the price of our common stock may subject us to securities litigation in the future.
  • Issuance of stock to fund our operations may dilute your investment and reduce your equity interest.
  • Upon the exercise of our outstanding warrant, holders of our common stock may experience immediate dilution and the market price of our common stock may be adversely affected.
  • We incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us.
  • If securities or industry analysts do not publish, or cease publishing, research reports about us, our business or our market, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
  • We do not foresee paying cash dividends in the foreseeable future.
  • Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to certain limitations.

Legal proceedings

Legal Malpractice Suit

On September 17, 2020, the Company filed a lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in Eshelman v. Puma Biotechnology, Inc., et al. in the Superior Court of Mecklenburg County, North Carolina. The Company is alleging legal malpractice based on the defendants’ negligent handling of the defense of the Company in Eshelman v. Puma Biotechnology, Inc., et al. The Company is seeking recovery of the entire amount awarded in Eshelman v. Puma Biotechnology, Inc., et al. and all legal fees and expenses incurred in appealing from the judgment and retrying the damages phase of the trial. On November 23, 2020, the defendant filed an answer to the complaint denying the allegations of negligence. On August 19, 2022, the Company filed a voluntary dismissal of the legal malpractice action, without prejudice, to allow the Eshelman v. Puma Biotechnology, Inc., et al. to conclude before proceedings. On June 2, 2023, the Company re-filed the lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in Eshelman v. Puma Biotechnology, Inc., et al. in the Superior Court of Mecklenburg County, North Carolina. On August 22, 2023, the defendants filed motions to dismiss the case. These motions were presented at a hearing on February 20, 2024. The Superior Court Judge granted the motions to dismiss on March 20, 2024. The Company appealed this ruling to the North Carolina Court of Appeals. On September 3, 2025, the Court of Appeals reversed the dismissal of the Company’s claim for legal malpractice and remanded the case to the Superior Court for further proceedings. The defendants filed a petition for discretionary review of this decision by the North Carolina Supreme Court on October 8, 2025. The Supreme Court has not decided whether to accept the case for review.

Patent-Related Proceedings

The opening of Item 3, Legal Proceedings.16

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