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Puma Biotechnology(PBYI) - 2022 Q3 - Quarterly Report
2022-11-03 20:45
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or ...
Puma Biotechnology(PBYI) - 2022 Q2 - Earnings Call Transcript
2022-08-07 15:38
Financial Data and Key Metrics Changes - Puma reported total revenue for Q2 2022 of $59.5 million, which includes product revenue net of $51.3 million, an increase from $40.7 million in Q1 2022 and $48.9 million in Q2 2021 [9][10] - Net income based on GAAP for Q2 2022 was $9.4 million or $0.21 per share, compared to a net loss of $3.4 million or $0.08 per share in Q1 2022 [45] - Gross revenue from NERLYNX sales was $63.4 million in Q2 2022, up from $51.5 million in Q1 2022 [46] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $2.7 million on inventory build at specialty pharmacies and distributors in Q2 2022 [9] - The company sold 3,200 bottles of NERLYNX in Q2 2022, an increase of 520 from Q1 2022 [11][32] - New prescriptions (NRx) were down approximately 8% compared to Q1, while total prescriptions (TRX) were up about 1.6% [11] Market Data and Key Metrics Changes - Approximately 79% of NERLYNX business went through the specialty pharmacy channel in Q2 2022, slightly down from 81% in Q1 2022 [29] - The extended adjuvant breast cancer market remains significantly under-penetrated, indicating potential growth opportunities [27] Company Strategy and Development Direction - The company remains focused on leveraging positive clinical data for NERLYNX, engaging patients, and enhancing field force execution [25] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio and leverage existing infrastructure [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertainty regarding the impact of COVID-19 on sales and revenue, but noted a positive trend in face-to-face interactions with healthcare providers [59] - The company anticipates Q3 2022 NERLYNX net sales in the range of $44 million to $47 million, with a net loss expected between $1 million and $2 million [50][52] Other Important Information - The company plans to submit final data from the SUMMIT trial to the FDA later this year [17] - Cash burn for Q2 2022 was approximately $14 million, down from $17 million in Q1 2022 [54] Q&A Session Summary Question: Changes in sales force structure due to increased live interactions - Management believes that a combination of live and virtual interactions will be the new normal, and they are currently satisfied with the size of the sales force [63][65] Question: Presentation of updated HER2-mutated breast cancer data - Management anticipates presenting updated data at the San Antonio Breast Cancer meeting, but the timing of FDA disclosures is uncertain [68] Question: Long-term profitability and cost management - Management reiterated the commitment to being net income positive and cash flow positive, with potential further cost cuts if necessary [77]
Puma Biotechnology(PBYI) - 2022 Q2 - Quarterly Report
2022-08-04 20:46
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or other ...
Puma Biotechnology(PBYI) - 2022 Q1 - Earnings Call Presentation
2022-05-06 10:09
Puma Biotechnology Earnings Call Commercial Update May 5, 2022 Forward-Looking Safe-Harbor Statement This presentation contains forward-looking statements, including statements regarding commercialization of NERLYNX® and the potential indications and development of our drug candidates. All forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statem ...
Puma Biotechnology(PBYI) - 2022 Q1 - Earnings Call Transcript
2022-05-06 02:05
Call Start: 16:30 January 1, 0000 5:10 PM ET Puma Biotechnology, Inc. (NASDAQ:PBYI) Q1 2022 Earnings Conference Call May 5, 2022 16:30 ET Company Participants Mariann Ohanesian - Senior Director of Investor Relations Alan Auerbach - Chairman, President & Chief Executive Officer Jeffrey Ludwig - Chief Commercial Officer Maximo Nougues - Chief Financial Officer Conference Call Participants Ed White - H.C. Wainwright Alex Hammond - Bank of America Operator Good afternoon. My name is Karen, and I will be your c ...
Puma Biotechnology(PBYI) - 2022 Q1 - Quarterly Report
2022-05-05 20:46
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or other jurisdiction of incorpo ...
Puma Biotechnology(PBYI) - 2021 Q4 - Earnings Call Transcript
2022-03-04 00:08
Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2021 Earnings Conference Call March 3, 2022 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, IR Alan Auerbach - Chairman, President & CEO Jeff Ludwig - Chief Commercial Officer Maximo Nougues - CFO Conference Call Participants Edward White - H.C. Wainwright Carly Kenselaar - Citi Marc Frahm - Cowen Alex Hammond - Bank of America Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timest ...
Puma Biotechnology(PBYI) - 2021 Q4 - Annual Report
2022-03-03 21:45
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934exhibit For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 ( ...
Puma Biotechnology(PBYI) - 2021 Q3 - Earnings Call Transcript
2021-11-05 02:25
Puma Biotechnology, Inc. (NASDAQ:PBYI) Q3 2021 Earnings Conference Call November 4, 2021 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, Investor Relations Alan Auerbach - Chairman, President and Chief Executive Officer Jeffrey Ludwig - Chief Commercial Officer Maximo Nougues - Chief Financial Officer Conference Call Participants Carly Kenselaar - Citi Marc Frahm - Cowen Alex Hammond - Bank of America Sheldon Fan - Barclays Operator Good afternoon. My name is Melinda, and I will be your ...
Puma Biotechnology(PBYI) - 2021 Q3 - Quarterly Report
2021-11-04 20:31
Table of Contents ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or ...