What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-10 compared with 2026-05-11 · 86 added, 46 removed, 122 unchanged (52% of the section changed)

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• Results of Operations.

This section provides an analysis of our results of operations presented in the accompanying condensed consolidated statements of operations and comprehensive loss by comparing the results for the three months ended March 31, 2026 and 2025.

• Liquidity and Capital Resources .

This section provides a discussion of our financial condition and liquidity, an analysis of our cash flows for the three months ended March 31, 2026 and 2025, and a discussion of our outstanding commitments and contingencies that existed as of March 31, 2026.

This section provides a discussion of our financial condition and liquidity, an analysis of our cash flows for the six months ended June 30, 2026 and 2025, and a discussion of our outstanding commitments and contingencies that existed as of June 30, 2026.

We are a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care.

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Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 receptor antagonist to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy).

CINVANTI is the first and only IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with Highly Emetogenic Cancer ("HEC") and nausea and vomiting associated with Moderately Emetogenic Cancer ("MEC") that is free of synthetic surfactants, including polysorbate 80.

CINVANTI is the first IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with Highly Emetogenic Cancer ("HEC") and nausea and vomiting associated with Moderately Emetogenic Cancer ("MEC") that is free of synthetic surfactants, including polysorbate 80.

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of MEC as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.

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in January 2018.

On June 1, 2026, the U.S.

District Court for the District of Delaware issued a decision in the patent litigation between the Company and Azurity Pharmaceuticals, Inc., Azurity Pharmaceuticals India LLP f/k/a Slayback Pharma India LLP, and Slayback Pharma LLC (“Azurity”), with respect to CINVANTI, holding that the asserted claims of Company’s U.S.

12,115,255 and 12,290,520 are invalid under 35 U.S.C.

The Court also entered a final judgment declaring that the asserted claims of U.S.

and 11,744,800 are not infringed.

This decision has no impact on any prior settlement agreement related to CINVANTI or APONVIE.

SUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both MEC and anthracycline and cyclophosphamide ("AC") combination chemotherapy regimens.

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in October 2016.

On June 15, 2026, we submitted a notification to the FDA that SUSTOL will no longer be available for sale as of September 30, 2026.

If we decide to recommence commercial marketing and sale of SUSTOL, we will notify the FDA before the anticipated launch date.

Biochronomer Technology

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Recent Events

There are no other material recent events during the three months ended March 31, 2026.

There are no other material recent events during the three or six months ended June 30, 2026.

Material Trends and Developments

There are no other material changes to our material trends and developments disclosures included in our 2025 Annual Report during the three months ended March 31, 2026.

There are no other material changes to our material trends and developments disclosures included in our 2025 Annual Report during the three or six months ended June 30, 2026.

Contractual Obligations and Commitments

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We are required to purchase certain quantities of such products through December 31, 2026, but our monthly payment for such products may be reduced for unreleased products or non-conforming products if the products are not released by specified release dates.

The Framework Agreement was effective on August 6, 2025 and will be in effect through and terminate automatically on December 31, 2026, other than with respect to any ongoing project addendums for stability studies entered into prior to December 31, 2026.

On November 13, 2025, we entered into Amendment No.

1 to Framework Agreement, pursuant to which certain payment terms were amended.

On July 20, 2026, we entered into Amendment No.

2 to Framework Agreement (the "Amendment No.

2 to Framework Agreement"), pursuant to which certain scheduled payments were deferred.

2 to Framework Agreement.

Lease Obligations

We have entered into two operating leases for laboratory and office space.

Our laboratory and office space in San Diego, California, a portion of which has been subleased to a third party, has a lease term that expires on December 31, 2025.

Our one five-year option to renew this lease on expiration applies only with respect to the portion of the premise that has not been subleased.

The lease for office space in Cary, North Carolina is expected to commence no later than May 25, 2026 and expire 111 months from the

lease commencement date, with the option to extend for one additional period of 84 months upon written notice.

As the lease commencement date has not yet occurred, no right-of-use asset or lease liability has been recognized in the accompanying condensed consolidated financial statements.

We provided the landlord with a letter of credit for $0.2 million, which is included within cash and cash equivalents in the condensed consolidated balance sheet.

Our laboratory and office space in San Diego, California, a portion of which had been subleased to a third party, had a lease term that expired on December 31, 2025.

The lease for office space in Cary, North Carolina has commenced on May 1, 2026 and expires 111 months from the lease commencement date, with the option to extend for one additional period of 84 months upon written notice.

Other Obligations and Contingencies

We, from time-to-time, are subject to claims and litigation in the normal course of the business.

We may also incur costs related to maintaining, defending, and enforcing patent claims, including litigation costs and the outcome of such litigation.

We have not reserved any amounts for contingencies related to such litigation because they are both not probable and reasonably estimable based on information currently available.

See "Part II.

Legal Proceedings" in this Quarterly Report on Form 10-Q for further discussion of pending legal proceedings.

Critical Accounting Estimates

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revenue recognition, investments, inventory and the related reserves, accrued clinical and manufacturing liabilities, income taxes, stock-based compensation and accounting for debt and equity transactions.

There are no material changes to our critical accounting estimates disclosures included in our 2025 Annual Report, during the three months ended March 31, 2026.

There are no material changes to our critical accounting estimates disclosures included in our 2025 Annual Report, during the three or six months ended June 30, 2026.

Recent Accounting Pronouncements

See Note 3 - Accounting Policies - Recent Accounting Pronouncements to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Results of Operations for the Three Months Ended March 31, 2026 and 2025

The following table summarizes the results of our operations for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Results of Operations for the Three and Six Months Ended June 30, 2026 and 2025

The following table summarizes the results of our operations for the three and six months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

($ in thousands)

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Net Product Sales

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Acute Care Net Product Sales

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Total Net Product Sales

Total acute care net product sales increased by $3.3 million or 32.3% during the three months ended March 31, 2026, as compared to the comparable period in 2025.

Total acute care net product sales increased by $4.7 million or 43.9% during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.

The increase was primarily attributable to an increase in the units sold as a result of an increase in market share and new customers for both ZYNRELEF and APONVIE.

Total oncology net product sales decreased by $7.5 million or 26.3% during the three months ended March 31, 2026, as compared to the comparable period in 2025.

The decrease was primarily attributable to a decrease in units sold.

Total acute care net product sales increased by $8.0 million or 38.2% during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

The increase was primarily attributable to an increase in the units sold as a result of an increase in market share and new customers for both ZYNRELEF and APONVIE.

Total oncology net product sales decreased by $4.2 million or 15.9% during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.

The decrease was primarily attributed to a decrease in units sold as a result of continued competitive pressure.

Total oncology net product sales decreased by $11.7 million or 21.3% during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

The decrease was primarily attributed to a decrease in units sold as a result of continued competitive pressure.

Cost of Product Sales and Gross Profit

Cost of product sales increased by $2.2 million or 25.8% during the three months ended March 31, 2026, as compared to the comparable period in 2025 and as a percentage of sales increased 8.9% during the same period.

Gross profit for the three months ended March 31, 2026 was 69.4%, compared to 78.3% for the comparable period in 2025.

The increase in cost of product sales for the three months ended March 31, 2026, as compared to the same period in 2025, is primarily attributable to an increase of $0.3 million of inventory reserves and write-offs recorded and an increase of $1.9 million in the cost of units sold, primarily due to supplier mix.

Cost of product sales increased by $1.7 million or 17.4% during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025 and as a percentage of sales increased 4.2% during the same period.

Cost of product sales increased by $3.9 million or 21.3% during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025 and as a percentage of sales increased 6.6% during the same period.

Gross profit for the three months ended June 30, 2026 was 69.3%, compared to 73.5% during the three months ended June 30, 2025.

Gross profit for the six months ended June 30, 2026 was 69.3%, compared to 75.9% during the six months ended June 30, 2025.

The increase in cost of product sales for the three months ended June 30, 2026, as compared to the same period in 2025, is primarily attributable to an increase of $0.5 million of inventory reserves and write-offs recorded and an increase of $1.2 million in the cost of units sold, primarily due to the increase in number of units sold and supplier mix.

The increase in cost of product sales for the six months ended June 30, 2026, as compared to the same period in 2025, is primarily attributable to an increase of $0.8 million of inventory reserves and write-offs recorded and an increase of $3.1 million in the cost of units sold, primarily due the increase in number of units sold and supplier mix.

Research and Development Expense

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Three Months Ended

Six Months Ended

ZYNRELEF-related costs

SUSTOL-related costs

CINVANTI-related costs

APONVIE-related costs

Personnel costs and other expenses

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Total research and development expense

Research and development expense increased by $0.1 million or 4.7%, during the three months ended March 31, 2026 compared to the same period in 2025.

The increase in costs is primarily attributable to an increase in contract services due to timing.

Research and development expense decreased by $0.2 million or 7.9%, during the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

The decrease is primarily attributable to a decrease in personnel expense of $0.2 million as a result of reduction in headcount.

Research and development expense decreased by $0.1 million or 2.4%, during the six months ended June 30, 2026 compared to the six months ended June 30, 2025.

The decrease is primarily attributable to a decrease in personnel expense of $0.3 million as a result of reduction in headcount and a decrease in asset write-offs of $0.1 million recorded in 2025 for which there was no similar expense in 2026, offset by an increase in expense with vendors of $0.2 million, due to timing.

General and Administrative Expense

General and administrative expense decreased by $0.6 million or 4.4%, during the three months ended March 31, 2026 compared to the same period in 2025.

The decrease in costs is primarily attributable to a decrease in rent expense of $1.0 million due to the termination of leases and a decrease in legal expenses of $0.9 million due to timing of litigation proceedings.

These decreases were offset by an increase in personnel related costs and stock compensation expense of $1.1 million due to an increase in headcount.

General and administrative expense decreased by $3.2 million or 22.1%, during the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

The decrease is primarily attributable to a decrease in legal fees of $2.6 million due to timing of litigation, a decrease in rent expense of $0.9 million due to the San Diego, California lease termination, and a decrease in expense with vendors of $0.3 million, due to less services provided by outside vendors.

These decreases were offset by an increase in personnel expense of $0.6 million due to an increase in headcount.

General and administrative expense decreased by $3.8 million or 13.8%, during the six months ended June 30, 2026 compared to the six months ended June 30, 2025.

The decrease is primarily attributable to a decrease in legal fees of $3.5 million due to timing of litigation and a decrease in rent expense of $1.9 million due to the San Diego, California lease termination.

These decreases were offset by an increase in personnel expense of $1.8 million due to an increase in headcount.

Sales and Marketing Expense

Sales and marketing expense increased by $2.0 million or 16.2%, during the three months ended March 31, 2026 compared to the same period in 2025.

The increase is primarily attributable to an increase in personnel related costs and stock compensation expense of $1.0 million due to an increase in headcount, and an increase in marketing expense, primarily related to ZYNRELEF, of $1.0 million.

Sales and marketing expense increased by $2.6 million or 22.3%, during the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

The increase is primarily attributable to an increase in personnel expense of $1.9 million related to an increase in headcount and an increase in marketing spend, primarily related to ZYNRELEF, of $0.7 million.

Sales and marketing expense increased by $4.6 million or 19.2%, during the six months ended June 30, 2026 compared to the six months ended June 30, 2025.

The increase is primarily attributable to an increase in personnel expense of $2.6 million related to an increase in headcount and an increase in marketing spend, primarily related to ZYNRELEF, of $2.0 million.

Other Expense, Net

For the three months ended March 31, 2026, other expense, net was $3.3 million, compared to $0.5 million, for the same period in 2025.

The increase in expense is related to the increase in interest expense of $2.3 million as a result of the debt refinancing completed in 2025 and the loss of sublease income of $0.3 million due to the San Diego, California lease termination.

For the three months ended June 30, 2026, other expense, net was $3.4 million, compared to $0.7 million, for the three months ended June 30, 2025.

The increase in expense is primarily attributable to an increase in interest expense of $2.3 million as a result of the debt refinancing completed in 2025 and the loss of sublease income of $0.3 million due to the San Diego, California lease termination.

For the six months ended June 30, 2026, other expense, net was $6.8 million, compared to $1.3 million, for the six months ended June 30, 2025.

The increase in expense is primarily attributable to an increase in interest expense of $4.6 million as a result of the debt refinancing completed in 2025 and the loss of sublease income of $0.7 million due to the San Diego, California lease termination.

Liquidity and Capital Resources

Sources of Liquidity

As of March 31, 2026, we had cash, cash equivalents and short-term investments of $44.8 million.

Our net loss for the three months ended March 31, 2026 was $8.1 million, or loss per share of $0.04, compared to net income of $2.6 million, or earnings per share of $0.02, for the same period in 2025.

We have incurred significant operating losses and negative cash flows from operations and had an accumulated deficit of $1.9 billion as of March 31, 2026.

From our inception through March 31, 2026, we have financed our growth and operations, including technology and product research and development, primarily through the issuance of common stock, convertible notes and warrants, product sales and debt financings.

Based on our current operating plan and projections, management believes that the Company's cash, cash equivalents and short-term investments will be sufficient to meet the Company's anticipated cash requirements for a period of at least one year from the issuance of the condensed consolidated financial statements

included in this Quarterly Report on Form 10-Q.

As of June 30, 2026, we had cash, cash equivalents and short-term investments of $42.7 million.

Our net loss for the three months ended June 30, 2026 was $5.5 million, or loss per share of $0.03, compared to net loss of $2.4 million, or loss per share of $0.02, for the same period in 2025.

Our net loss for the six months ended June 30, 2026 was $13.6 million, or loss per share of $0.07, compared to net income of $0.3 million, or nil earnings per share, for the same period in 2025.

We have incurred significant operating losses and negative cash flows from operations and had an accumulated deficit of $1.9 billion as of June 30, 2026.

From our inception through June 30, 2026, we have financed our operations, including technology and product research and development, primarily through the issuance of common stock, convertible notes and warrants, product sales and debt financings.

Subsequent to the receipt of the Fourth Amendment to the Working Capital Facility Agreement (described further below) and based on our current operating plan and projections, management believes that the Company's cash, cash equivalents and short-term investments will be sufficient to meet the Company's anticipated cash requirements for a period of at least one year from the issuance of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect, which would have a material impact on our operations.

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Our future cash requirements and the adequacy of our available funds will depend on many factors, primarily including our ability to generate revenue and the scope and costs of our commercial and research and development activities.

We were in compliance with all covenants of the Third Amendment to the Working Capital Facility Agreement as of March 31, 2026.

Our Working Capital Facility Agreement contains a minimum cash covenant, a minimum revenue covenant and a minimum EBITDA covenant.

In the event of a default under the Working Capital Facility Agreement or any future debt agreement, our lenders could declare all outstanding principal, together with accrued and unpaid interest, to be immediately due and payable.

If the payment of the debt is accelerated, cash flows from our operations may be insufficient to repay such debt in full.

On August 7, 2026, we entered into a Waiver, Consent, and Fourth Amendment to the Working Capital Facility Agreement (the “Fourth Amendment to the Working Capital Facility Agreement”) to the Initial Working Capital Facility Agreement, as amended by the First Amendment to the Working Capital Facility Agreement, the Second Amendment to the Working Capital Facility Agreement and the Third Amendment to the Working Capital Facility Agreement.

The Fourth Amendment to the Working Capital Facility Agreement, among other things, (a) waives the minimum revenue and minimum EBITDA financial covenants for the fiscal quarter ended June 30, 2026 and (b) amends the Working Capital Facility Agreement to (i) require a prepayment by the Company of $17,500,000 in principal amount outstanding under the Working Capital Facility Agreement (the “Prepayment”), consisting of a $13,500,000 prepayment made upon effectiveness of the Fourth Amendment to the Working Capital Facility Agreement and a second prepayment of up to $4,000,000 due on or before September 15, 2026 (which second prepayment may be reduced, including to zero, if certain conditions set forth therein are met), together with End of Term Fees of $661,500 and up to $196,000, respectively, plus accrued PIK Interest (as defined under the Fourth Amendment to the Working Capital Facility Agreement) due on such Prepayment with any fees associated with the Prepayment to be waived, (ii) eliminate the future availability of $20.0 million through December 15, 2026 (“tranche 2”) and $20.0 million through September 30, 2027 (“tranche 3”), (iii) revises the minimum revenue covenant, the minimum EBITDA covenant and the minimum cash covenant effective as of the reporting period ending August 31, 2026, (iv) permits the Company to enter into an agreement for certain products, subject to the lenders' approval of the final terms, and (v) includes certain other covenants regarding other potential strategic transactions.

A failure to comply with the covenants under our Working Capital Facility Agreement in future periods could result in an event of default unless further waivers or amendments are obtained, of which there is no assurance.

The net change in cash and cash equivalents consisted of the following:

Our net cash used in operating activities for the three months ended March 31, 2026 and 2025 was $1.5 million and $8.9 million, respectively.

The decrease in net cash used in operating activities of $7.4 million or 82.6%, was primarily attributable to the net loss of $8.1 million for the three months ended March 31, 2026 compared to net income of $2.6 million for the three months ended March 31, 2025, as well as payments for inventory, accounts payable, and accrued clinical and manufacturing liabilities.

Our net cash used in investing activities for the three months ended March 31, 2026 was $0.9 million compared to net cash provided by investing activities for the three months ended March 31, 2025 was $2.3 million.

The change in net cash used in investing activities of $3.2 million, was primarily attributable to net purchases of short-term investments of $0.5 million for the three months ended March 31, 2026 compared to net maturities of short-term investments of $2.3 million for the three months ended March 31, 2025.

Our net cash used in financing activities for the three months ended March 31, 2026 was $0.05 million, compared to net cash provided by financing activities for the three months ended March 31, 2025, which was $0.06 million.

Our net cash used in operating activities for the six months ended June 30, 2026 and 2025 was $3.8 million and $19.7 million, respectively.

The decrease in net cash used in operating activities of $15.9 million or 81.0%, was primarily attributable to variability in payments for operating assets and liabilities including, inventory, prepaid expenses and other assets, accounts payable and accrued clinical and manufacturing liabilities, offset by the net loss of $13.6 million for the six months ended June 30, 2026 compared to net income of $0.3 million for the six months ended June 30, 2025.

Our net cash used in investing activities for the six months ended June 30, 2026 was $4.2 million compared to net cash provided by investing activities for the six months ended June 30, 2025, which was $9.6 million.

The change in net cash used in investing activities of $13.8 million, was primarily attributable to net purchases of short-term investments of $3.7 million for the six months ended June 30, 2026 compared to net maturities of short-term investments of $9.9 million for the six months ended June 30, 2025.

Our net cash used in financing activities for the six months ended June 30, 2026 was $0.03 million, compared to net cash provided by financing activities for the six months ended June 30, 2025, which was $0.9 million.

Material Cash Requirements

There are no material changes to our material cash requirements disclosures included in our 2025 Annual Report during the three months ended March 31, 2026.

There are no material changes to our material cash requirements disclosures included in our 2025 Annual Report during the three and six months ended June 30, 2026.

Off-Balance Sheet Arrangements

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Quantitative and qualitative disclosures about market risk are included in "Management's Discussion and Analysis of Financial Condition and Results of Operations - Quantitative and Qualitative Disclosures about Market Risk" in our 2025 Annual Report.

There are no material changes to the quantitative and qualitative disclosures included in our 2025 Annual Report during the three months ended March 31, 2026.

There are no material changes to the quantitative and qualitative disclosures included in our 2025 Annual Report during the three and six months ended June 30, 2026.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis