Yes, well.
We have continued our focus on maintaining tight control of net cash usage for operating activities, which was $63.3 million for the year ended June 30, 2023. As of June 30, 2023, we held total cash reserves of $71.3 million. We are implementing various cost containment and deferment strategies, including the reprioritization of projects and operational streamlining to manage net operating cash usage. In August 2023, the FDA provided a complete response to our BLA resubmission for remestemcel-L for the treatment of pediatric SR-aGVHD and requires more data to support marketing approval, including potency assay or clinical data. In line with our overall commercial strategy to progress to adult populations, we intend to conduct a targeted, controlled study in the highest-risk adults with the greatest mortality. In conjunction with implementing cost containment and deferment strategies, additional inflows from royalty monetization, capital markets, strategic partnerships or product specific financing will be required to meet our projected expenditure consistent with our business strategy over at least the next 12 months. As a result of these matters, there is material uncertainty related to events or conditions that may cast significant doubt (or raise substantial doubt as contemplated by Public Company Accounting Oversight Board (“PCAOB”standards) on our ability to continue as a going concern and, therefore, that we may be unable to realize our assets and discharge our liabilities in the normal course of business. Our consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. If we are unable to obtain adequate funding or partnerships beyond the 12-month period we may not be able to continue as a going concern, and our shareholders and holders of the ADSs may lose some or all of their investment in Mesoblast.
The terms of our loan facilities with funds associated with Oaktree Capital Management, L.P. (“Oaktree”and NovaQuest Capital Management, L.L.C. (“NovaQuest”
could restrict our operations, particularly our ability to respond to changes in our business or to take specified actions. On November 19, 2021, we entered into a loan agreement and guaranty with Oaktree, for a $90.0 million, five-year senior debt facility. We drew the first tranche of $60.0 million at closing. We will seek to extend our option to draw the additional $30.0 million tranche beyond September 30, 2023, subject to us achieving certain milestones. On June 29, 2018, we entered into a loan and security agreement with NovaQuest for a $40.0 million non-dilutive, eight-year term credit facility, repayable from net sales of our allogeneic product candidate remestemcel-L in pediatric patients with steroidrefractory acute graft versus host disease (“SR-aGVHD”
, in the United States and other geographies excluding Asia. We drew the first tranche of $30.0 million on closing. Our loan facilities with Oaktree and NovaQuest contain a number of covenants that impose operating restrictions on us, which may restrict our ability to respond to changes in our business or take specified actions. Under the terms of our Oaktree agreement the minimum unrestricted cash balance we need to maintain is $35.0 million. Our ability to comply with the various covenants under the agreements may be affected by events beyond our control, and we may not be able to continue to meet the covenants. Upon the occurrence of an event of default, Oaktree or NovaQuest could elect to declare all amounts outstanding under the loan facility to be immediately due and payable and terminate all commitments to extend further credit. If Oaktree or NovaQuest accelerates the repayment, we may not have sufficient funds to repay our existing debt. If we were unable to repay the owed amounts, Oaktree or NovaQuest could proceed against the collateral granted to it to secure such indebtedness. We have pledged substantially all of our assets as collateral under the loan facility with Oaktree, and a portion of our assets relating to the SR-aGVHD product andidate as collateral under the loan facility with NovaQuest.
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97.0¢ |
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Mkt cap ! $1.107B |
Open | High | Low | Value | Volume |
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1 | 23000 | 0.960 |
4 | 56273 | 0.955 |
5 | 46225 | 0.950 |
2 | 65500 | 0.945 |
Price($) | Vol. | No. |
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0.970 | 50000 | 2 |
0.975 | 20000 | 1 |
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