On November 7, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the third quarter of 2022 (Press release, Y-mAbs Therapeutics, NOV 7, 2022, View Source [SID1234623282]).
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"The third quarter marked significant progress for DANYELZA. We are thrilled to report record sales of $12.5 million, a 28% increase compared to the previous quarter. In addition, DANYELZA was approved in Israel and submitted for marketing authorization in Brazil, and we look forward to our partners’ continued efforts to expand DANYELZA," said Thomas Gad, President and Interim Chief Executive Officer. "While we are truly disappointed by the outcome of the recent ODAC meeting for omburtamab after working tirelessly to receive breakthrough designation and submit the BLA to the FDA, we remain steadfast in our commitment to patients and caregivers who do not have access to an approved treatment, where there is a clear unmet need. However, while we await FDA’s formal decision on the BLA, we remain confident knowing that that Y-mAbs has never been defined by a single program or technology. Our expertise spans multiple verticals and disciplines, and we continue to invest confidently in our future with the promise of SADA while looking to maximize DANYELZA as the cornerstone of a sustainable pediatric oncology franchise funded by a strong balance sheet with $114.5 million in cash that is sufficient to support our business operations as currently planned into mid-2024."
Third Quarter 2022 and Recent Corporate Developments
On October 28, Y-mAbs announced the outcome of the FDA Oncologic Drugs Advisory Committee meeting, where the committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival
On October 3, Y-mAbs announced pivotal data from Study 101 for omburtamab in CNS/LM metastasis from neuroblastoma at the International Society of Pediatric Oncology (SIOP) annual congress
On September 26, Y-mAbs announced a regulatory filing for DANYELZA for the treatment of neuroblastoma in Brazil by Adium Pharma
On August 30, Y-mAbs announced that Takeda received marketing authorization for DANYELZA for the treatment of neuroblastoma in Israel
On July 12, Y-mAbs announced clearance of the IND for GD2-SADA
Financial Results
Revenues
Y-mAbs reported net revenues of $12.5 million and $33.8 million for the third quarter 2022 and nine months ended September 30, 2022, which represented increases of 40% and 34%, respectively, over $9.0 million and $25.3 million in the comparable periods of 2021. Net revenues in the nine months ended September 30, 2022 included $1.0 million of license revenue, compared to $2.0 million of license revenue in the corresponding period in 2021.
DANYELZA product revenue for the third quarter 2022 and nine months ended September 30, 2022, was $12.5 million and $32.8 million, respectively, which represented increases of 40% and 41%, respectively, over the corresponding periods in 2021 and an increase of 28% compared to the second quarter of 2022 DANYELZA product revenues of $9.8 million. The increase was primarily driven by an increase in the number of new U.S. patients in treatment during the third quarter of 2022.
As of September 30, 2022, Y-mAbs has delivered DANYELZA to 43 centers across the United States, corresponding to an increase of more than 19% in the number of centers since the end of the second quarter of 2022. During the third quarter of 2022, approximately 40% of the vials sold in the United States were sold outside Memorial Sloan Kettering ("MSK"), a decrease from the prior quarter as a result of MSK’s growth of new patients outpacing the growth of new patients at institutions outside MSK.
Operating Expenses
Research and Development
Research and development expenses were $22.4 million for the three months ended September 30, 2022, compared to $23.1 million for the three months ended September 30, 2021. The $0.7 million decrease reflects decreased spending for clinical trials, partially offset by increased costs for outsourced manufacturing services. Having completed the resubmission of the BLA for omburtamab in the first quarter of 2022, we are focusing on pipeline development programs for potential DANYELZA label expansion and advancing SADA constructs into the clinic.
Research and development expenses increased by $7.3 million to $71.8 million during the nine months ended September 30, 2022, compared to the prior year period. The $7.3 million increase mainly reflects an increase in outsourced manufacturing services and increased personnel costs dedicated to our advancement of DANYELZA, omburtamab, and the SADA constructs.
Selling, General, and Administration
Selling, general, and administrative expenses decreased by $0.4 million to $13.6 million for the three months ended September 30, 2022, compared to $14.0 million for the three months ended September 30, 2021. The decrease in selling, general and administrative expenses was primarily the result of a $2.1 million decrease in salary and stock-based compensation expense, partially offset by increased costs related to the commercialization of DANYELZA.
Selling, general, and administrative expenses increased by $10.7 million to $50.1 million for the nine months ended September 30, 2022, compared to $39.4 million for the nine months ended September 30, 2021. The increase in selling, general, and administrative expenses was primarily attributable to an $8.9 million increase in severance and share-based compensation expense related to our former chief executive officer in the nine months ended September 30, 2022, and to a lesser extent, the commercialization of DANYELZA.
Net Loss
We reported a net loss for the quarter ended September 30, 2022 of $27.5 million, or $0.63 per basic and diluted share, compared to a net loss of $28.9 million, or $0.66 per basic and diluted share for the quarter ended September 30, 2021. The decrease in net loss was primarily driven by the positive gross profit impact from increased revenues.
We reported a net loss for the nine months ended September 30, 2022 of $96.7 million, or $2.21 per basic and diluted share, compared to a net loss of $18.4 million, or $0.43 per basic and diluted share, for the nine months ended September 30, 2021. Net loss in the nine months ended September 30, 2021 included a $62.0 million net gain from the sale of our DANYELZA Priority Review Voucher, after sharing 40% of the net proceeds from the sale with MSK, pursuant to the terms of our license agreement with MSK. The increase in net loss in the nine months ended September 30, 2022 also reflects the impact of contractual severance-related benefits for our former chief executive officer, and increased research and development expenses, both as noted above, partially offset by the gross profit impact of DANYELZA’s revenue growth.
Cash and Cash Equivalents
We had approximately $114.5 million in cash and cash equivalents as of September 30, 2022, and we continue to expect a full-year 2022 cash burn of $78-83 million. Our cash and cash equivalents balance, when combined with anticipated DANYELZA revenues, is expected to be sufficient to fund our operations as currently planned into mid-2024. This estimate is based on our current business plan, and we have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
This estimate does not include any potential product revenues for omburtamab, if approved, or any potential net proceeds from the potential receipt and sale of any priority review voucher, which we expect would be awarded to us if we receive approval of omburtamab. The estimate assumes receipt of a regulatory milestone payment for DANYELZA approval in China, but no new partnerships or other new business development-related sources of income.
Financial Guidance
Management reiterates all elements of its 2022 financial guidance including, anticipated:
DANYELZA product revenues of $45-$50 million;
Operating expenses of $162-167 million;
Total cash burn of $78-83 million; and
Cash position sufficient to fund current operations as planned into mid-2024.
The DANYELZA revenue guidance includes an incremental benefit from international revenues. We will review operating expenses based on final FDA feedback on the omburtamab BLA but expect no adverse impact on cash runway.
Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, November 8, 2022, at 4 p.m. Eastern Time. To participate in the call, please dial 877-300-8521 (domestic) or 412-317-6026 (international) and reference the conference ID 10172741.
A webcast will be available at: View Source;tp_key=92279e61e6