On August 8, 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 second quarter of 2022 (Press release, Y-mAbs Therapeutics, AUG 8, 2022, View Source [SID1234617850]).
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"The highlight of the second quarter was FDA acceptance of our BLA filing for omburtamab," said Thomas Gad, President, and Interim Chief Executive Officer. "We are excited about the upcoming PDUFA date, which we believe brings us closer to the potential approval and achieving our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors. We were also thrilled to announce that the Phase 2 naxitamab chemo-immunotherapy trial met primary endpoints achieving an impressive response rate further underscoring DANYELZA potential in high-risk neuroblastoma. Our strong balance sheet with $133.7 million in cash is expected to support us through multiple potentially value-creating catalysts and into mid-2024."
Second Quarter 2022 and Recent Corporate Developments
On July 12, 2022, Y-mAbs announced clearance of the IND for GD2-SADA
On May 31, 2022, Y-mAbs announced FDA acceptance of the Biologics License Application for OMBLASTYS (omburtamab) for the treatment of neuroblastoma for priority review
On May 26, 2022, Y-mAbs announced that the naxitamab chemoimmunotherapy investigational trial for High-Risk Neuroblastoma met its primary endpoint. The data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
On April 27, 2022, Y-mAbs announced a management change. Dr. Claus Moller stepped down as Chief Executive Officer and Board Member, and the role of Interim Chief Executive Officer was assumed by Thomas Gad, the Company’s Founder and President, Interim Chief Executive Officer and Head of Business Development and Strategy, and Board Member. The Board, under the newly appointed Chairman, Dr. Jim Healy, has begun a search for Dr. Moller’s successor.
On April 8, 2022, Y-mAbs presented pre-clinical data from the GD2-SADA construct at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.
Financial Results
Revenues
Y-mAbs reported net revenues of $10.8 million and $21.3 million for the quarter and six months ended June 30, 2022, which represented a decrease of 1% and an increase 30%, respectively, over $11.0 million and $16.3 million in the comparable periods of 2021. Net revenues in the quarter and six months ended June 30, 2022 included $1.0 million of license revenue, compared to $2.0 million of license revenue in the corresponding periods in 2021. DANYELZA product revenue for the quarter and six months ended June 30, 2022 was $9.8 million and $20.3 million, respectively, which represented increases of 9% and 42%, respectively, over the corresponding periods in 2021. DANYELZA product revenue of $9.8 million in the second quarter 2022 deceased 7% compared to the first quarter of 2022 DANYELZA product revenues of $10.5 million. The decline included a slight decrease in new US patients earlier in the second quarter 2022, followed by a rebound in June, while international revenues benefitted from increased royalty income from partner’s sales, offset by a decrease in volume due to the timing of partner orders.
We have now delivered DANYELZA to 36 centers across the U.S., corresponding to an increase of 6% in the number of centers since the end of the first quarter of 2022. During the second quarter of 2022, approximately 40% of the vials sold in the U.S. were sold outside Memorial Sloan Kettering ("MSK"), a decrease from the prior quarter as a result of a decreased number of new patients at institutions outside MSK earlier in the second quarter followed by a rebound in June, as noted above, all while new patients at MSK continued to grow.
Operating Expenses
Research and Development
Research and development expenses were $26.4 million for the three months ended June 30, 2022, compared to $19.8 million for the three months ended June 30, 2021. The $6.6 million increase reflects an increase in outsourced manufacturing, inclusive of $2.9 million of naxitamab inventory vials that were designated for use in clinical trials during the three months ended June 30, 2022, our increased clinical trial activity and employee-related costs. Having completed the resubmission of the BLA for omburtamab in the first quarter 2022, we are focusing on pipeline development programs for potential DANYELZA label expansion, omburtamab and advancing the SADA constructs into the clinic.
Research and development expenses increased by $8.0 million to $49.3 million during the six months ended June 30, 2022 compared to the prior year period. The $8.0 million increase reflects an increase in outsourced manufacturing, inclusive of $2.9 million of naxitamab inventory vials that were designated for clinical use during the six months ended June 30, 2022, and our increased clinical trial activity, with particular focus on the DANYELZA, omburtamab and SADA technologies.
Selling, General, and Administration
Selling, General, and Administrative expenses increased by $9.6 million and $11.1 million, to $23.1 million and $36.5 million, for the quarter and six months ended June 30, 2022, respectively, compared to the prior year periods. The increase in selling, general and administrative expenses in both periods was primarily the result of a $10.7 million charge related to contractual severance related benefits for our former Chief Executive Officer, which was inclusive of $9.3 million of non-cash share-based compensation expense, and, to a lesser extent, the launch and commercialization of DANYELZA, which include employee-related costs and commercial expenses.
Net Loss
We reported a net loss for the quarter ended June 30, 2022, of $41.1 million, or $0.94 per basic and diluted share, compared to net loss of $22.9 million, or $0.53 per basic and diluted share for the quarter ended June 30, 2021. The decrease in earnings was primarily driven by the $10.7 million charge for contractual severance related benefits for our former Chief Executive Officer and increased research and development expenses focused on pipeline development programs for DANYELZA label expansion, omburtamab, and advancing the SADA constructs into the clinic.
We reported a net loss for the six months ended June 30, 2022, of $69.2 million, or $1.58 per basic and diluted share, compared to a net income of $10.5 million, or $0.25 per basic share and $0.23 per diluted share, for the six months ended June 30, 2021. Net income in the six months ended June 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 decrease in earnings in the six months ended June 30, 2022 also reflects the unfavorable impact of a $10.7 million charge for contractual severance related benefits for our former Chief Executive Officer, and increased research and development expenses, both as noted above, partially offset by the favorable impact of DANYELZA’s growing revenues.
Cash and Cash Equivalents
We had approximately $133.7 million in cash and cash equivalents as of June 30, 2022, and we continue to expect full year 2022 cash burn of $78-83 million. Our cash and cash equivalents balance of approximately $133.7 million as of June 30, 2022, which, when combined with forecasted DANYELZA revenue growth, is expected to be sufficient to fund our operations as currently planned into mid-2024. This estimate is based on our current business plan. 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 assumption for net proceeds received on the anticipated priority review voucher, which we could sell upon the potential approval of omburtamab. In addition, no new partnerships or other new business development-related sources of income are included in the assumptions, potential omburtamab revenues upon approval are also excluded, and the DANYELZA revenues are only assumed to increase modestly each year for the purpose of this analysis of runway.
Financial Guidance
Management reiterates all elements of its financial guidance including:
DANYELZA 2022 revenues of $45-$50 million;
Operating expenses of $162-167 million;
Total cash burn of $78-83 million for 2022; and
Cash position sufficient to fund current operations into mid-2024.
The revenue guidance includes an incremental benefit from international revenues.
Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, August 9, 2022, at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the conference ID 13730680.
A webcast will be available at: View Source;tp_key=db740a8735