3 unchanged sentences
(In thousands, except share and per share data)
+Added: September 30,
Current assets:
23 unchanged sentences
Preferred stock, par value $ 0.01 per share, 20,000,000 shares authorized;
−Removed: none issued and outstanding at June 30, 2024 and December 31, 2023.
−Removed: Common stock, par value $ 0.01 per share, 150,000,000 shares authorized at June 30, 2024 and December 31, 2023;
−Removed: 57,944,159 and 61,128,597 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively.
+Added: none issued and outstanding at September 30, 2024 and December 31, 2023.
+Added: Common stock, par value $ 0.01 per share, 150,000,000 shares authorized at September 30, 2024 and December 31, 2023;
+Added: 57,949,760 and 61,128,597 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively.
Additional paid-in capital
7 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
Costs and expenses:
23 unchanged sentences
Balance at June 30, 2024
+Added: Issuance of common stock upon exercise of stock options
+Added: Stock-based compensation expense
+Added: Balance at September 30, 2024
Balance at January 1, 2023
4 unchanged sentences
Balance at June 30, 2023
+Added: Issuance of common stock upon exercise of stock options
+Added: Stock-based compensation expense
+Added: Balance at September 30, 2023
See accompanying Notes to Condensed Consolidated Financial Statements
2 unchanged sentences
(In thousands)
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
Operating activities:
1 unchanged sentence
Stock-based compensation expense
−Removed: Non-cash interest earned on royalty obligation
Amortization of discount and issuance costs on convertible notes
5 unchanged sentences
government treasury bills, net
+Added: Non-cash interest on royalty obligation
Changes in operating assets and liabilities:
4 unchanged sentences
Investing activities:
−Removed: Purchases of investments
Proceeds from the sale and maturities of investments
+Added: Purchases of investments
Purchases of property and equipment
4 unchanged sentences
Cash paid to repurchase 2026 convertible senior notes
−Removed: Repurchases of common stock
Principal payments on OMIDRIA royalty obligation
+Added: Repurchases of common stock
Principal payments on finance lease obligations
Net cash provided by (used in) financing activities
−Removed: Net increase in cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
8 unchanged sentences
Note 1 — Organization and Basis of Presentation
−Removed: Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic disorders including complement-mediated diseases, as well as cancers and addictive and compulsive disorders.
+Added: Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic disorders including complement-mediated diseases, as well as cancers and addictive and compulsive disorders.
Our clinical-stage development programs include:
7 unchanged sentences
We appealed FDA’s decision to issue the CRL through a formal dispute resolution process that concluded in late 2022.
−Removed: Although our appeal was denied, the decision identified potential paths for resubmission of the BLA based on data from our completed pivotal trial and submission of additional evidence and analyses.
−Removed: We are having ongoing discussions with the agency regarding the data and analyses required to be included in a potential resubmission of our BLA.
−Removed: As a result, we are currently unable to estimate when we will submit the BLA or, subsequently, FDA’s timing for a decision regarding approval.
−Removed: There can be no guarantee that FDA's specific recommendations for resubmission will be acceptable to us in terms of the time and/or expenditure required or that any resubmission of the BLA will result in approval of narsoplimab for TA-TMA.
+Added: Although our appeal was denied, the decision identified potential paths for resubmission of the BLA, including paths based on comparison of survival data from our completed pivotal trial previously submitted to FDA an analysis plan to assess survival data from our completed clinical trial, existing data from a historical control population available from an external source, and data from the narsoplimab expanded access program.
+Added: As a part of our most recent meeting with FDA, in September 2024, we received minor feedback on our proposed statistical analysis plan for the primary endpoint – patient survival in our pivotal narsoplimab trial compared to that in an external registry of TA-TMA patients – which was a limited request to include certain additional sensitivity analyses.
+Added: Additional sensitivity analyses were quickly incorporated into the plan and sent back to FDA.
+Added: FDA’s reply is expected in November 2024.
+Added: We have no other information requests pending and are not aware of any other impediment to resubmitting our narsoplimab BLA.
+Added: After receiving FDA’s response and, assuming general alignment on the revised plan, we intend to proceed with conducting the primary and secondary efficacy analyses.
+Added: If the results support resubmission, then we intend to finalize and resubmit our BLA as soon as possible.
+Added: We are currently unable to provide a specific estimate of when or if we will resubmit the BLA or, subsequently, FDA’s timing for a decision regarding approval.
+Added: Even if the results of the efficacy analysis are favorable and FDA accepts our resubmitted BLA for review, as with any BLA or new drug application, there can be no guarantee that FDA will approve narsoplimab for TA-TMA.
Our lectin pathway program also includes OMS1029, our long-acting antibody targeting MASP-2.
3 unchanged sentences
We are evaluating several potential indications for Phase 2 clinical development of OMS1029.
−Removed: Our pipeline of clinical-stage complement-targeted therapeutic candidates also includes zaltenibart (also known as OMS906), a proprietary, patented monoclonal antibody targeting MASP-3, the key activator of the alternative pathway of complement.
−Removed: We have three ongoing Phase 2 clinical trials evaluating zaltenibart for the treatment of paroxysmal nocturnal hemoglobinuria (“PNH”).
+Added: Our pipeline of clinical-stage complement-targeted therapeutic candidates also includes zaltenibart, a proprietary, patented monoclonal antibody targeting MASP-3, the key activator of the alternative pathway of complement.
+Added: We have three ongoing clinical trials evaluating zaltenibart for the treatment of paroxysmal nocturnal hemoglobinuria (“PNH”).
The first is in PNH patients who have not previously been treated with a complement inhibitor, and the second is in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab.
−Removed: The third Phase 2 clinical trial is an open-label extension study to assess the long-term efficacy and safety of zaltenibart in patients who have completed either of the other two PNH Phase 2 clinical trials.
−Removed: We also have an ongoing Phase 2 clinical program evaluating zaltenibart for the treatment of C3G, a rare and debilitating renal disease driven by complement dysregulation.
+Added: The third clinical trial is an open-label extension study to assess the long-term efficacy and safety of zaltenibart in patients who have completed either of the other two PNH Phase 2 clinical trials.
+Added: We also have an ongoing clinical program evaluating zaltenibart for the treatment of C3G, a rare and debilitating renal disease driven by complement dysregulation.
Our phosphodiesterase 7 (“PDE7”) inhibitor program, which we refer to as OMS527, comprises multiple PDE7 inhibitor compounds and is based on our discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder, and between PDE7 and any movement disorders.
4 unchanged sentences
The toxicology study is underway and is expected to be completed later this year.
+Added: Assuming that the results support further development, we expect enrollment in the study evaluating OMS527 in adult patients with CUD to begin in 2025, also fully funded by NIDA.
We also have various programs in preclinical research and development.
12 unchanged sentences
On June 3, 2024, we, with certain subsidiaries, as guarantors, entered into a Credit and Guaranty Agreement (the “Credit Agreement”) with funds managed by Athyrium Capital Management LP (collectively, “Athyrium”) and funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”) as lenders (the “Lenders”).
−Removed: The Credit Agreement provides for a senior secured term loan facility of up to $ 92.1 million, consisting of an initial term loan of $ 67.1 million (the “Initial Term Loan”) and a $ 25.0 million delayed draw term loan which may be drawn once in full, on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA (the “Delayed Draw Term Loan”).
−Removed: Also on June 3, 2024, we used the Initial Term Loan along with $ 21.2 million of cash on hand, to repurchase from the Lenders $ 118.1 million aggregate principal of our existing 5.25 % convertible senior notes due on February 15, 2026 (the “2026 Notes” and such repurchase, the “2026 Note Repurchase Transaction”), which resulted in a $ 51.0 million reduction in outstanding debt.
+Added: The Credit Agreement provides for a senior secured term loan facility of up to $ 92.1 million, consisting of an initial term loan of $ 67.1 million (the “Initial Term Loan”) and a $ 25.0 million delayed draw term loan (the “Delayed Draw Term Loan”), which may be drawn once in full upon notice delivered on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the notice.
+Added: Also on June 3, 2024, we used the Initial Term Loan along with $ 21.2 million of cash on hand, to repurchase from the Lenders $ 118.1 million aggregate principal amount of our existing 5.25 % convertible senior notes due on February 15, 2026 (the “2026 Notes” and such repurchase, the “2026 Note Repurchase Transaction”), which resulted in a $ 51.0 million reduction in outstanding debt.
In addition, we paid accrued and unpaid interest on the repurchased 2026 Notes through the closing date of the transaction.
9 unchanged sentences
Liquidity and Capital Resources
−Removed: As of June 30, 2024, we had cash, cash equivalents and short-term investments of $ 158.9 million.
−Removed: For the six months ended June 30, 2024, our cash used in operations was $ 87.8 million.
−Removed: The second quarter of 2024 includes a $ 17.6 million charge for delivery of narsoplimab drug substance.
−Removed: In addition, we made a $ 21.2 million payment for term loan-related debt repurchase and incurred $ 1.9 million of term loan-related transaction costs.
−Removed: Pursuant to a covenant in the Credit Agreement entered on June 3, 2024, we must maintain at all times at least $ 25.0 million of unrestricted cash and cash equivalents.
−Removed: Historically, we have incurred net losses from continuing operations and negative operating cash flows.
−Removed: We have not yet established an ongoing source of revenue sufficient to cover our operating costs;
−Removed: therefore, we potentially need to continue to raise additional capital to accomplish our business plan.
−Removed: We have a sales agreement to sell shares of our common stock, from time to time, in an “at the market” equity offering facility through which we may offer and sell shares of our common stock equaling an aggregate amount up to $ 150.0 million.
−Removed: In addition, our Delayed Draw Term Loan of $ 25.0 million may be drawn once in full on or prior to June 3, 2025 at our election, but it is conditioned on the approval by FDA of narsoplimab in TA-TMA.
+Added: As of September 30, 2024, we had cash, cash equivalents and short-term investments of $ 123.2 million.
+Added: For the nine months ended September 30, 2024, our cash used in operations was $ 119.8 million.
+Added: This includes an $ 18.4 million charge for delivery of narsoplimab drug substance.
+Added: In addition, we made a $ 21.2 million payment to repurchase $ 118.1 million of our 2026 Notes.
+Added: Pursuant to a covenant in the Credit Agreement entered on June 3, 2024, we must maintain $ 25.0 million of unrestricted cash and cash equivalents at all times.
+Added: In recent years, Omeros has incurred net losses from continuing operations and negative cash flows from operations.
+Added: The recurring losses, in combination with our cash and investment balances as of September 30, 2024, and an expected repayment of a portion of our outstanding debt on or prior to November 2025, raises substantial doubt about our ability to continue as a going concern.
+Added: The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to our ability to continue as a going concern.
+Added: As we currently do not have an ongoing source of revenue sufficient to cover our operating costs, we will need to raise additional capital to accomplish our business plan.
+Added: We have a sales agreement to sell shares of our common stock, from time to time, in an “at the market” equity offering facility through which we may offer and sell shares of our common stock equaling an aggregate amount of up to $ 150.0 million.
+Added: In addition, our Delayed Draw Term Loan of $ 25.0 million may be drawn once in full upon notice delivered on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the notice.
Proceeds of the Delayed Draw Term Loan may only be used towards any related transaction costs and for commercialization of narsoplimab efforts of TA-TMA.
We may pursue additional debt financings to retire the 2026 Notes that remain outstanding and to fund operations.
−Removed: Should it be determined to be strategically advantageous, we could pursue public and private offerings of our equity securities, or other strategic transactions, which may include licensing or selling a portion or all of one or more of our existing technologies.
+Added: Should it be necessary or determined to be strategically advantageous, we may also pursue public and private offerings of our equity securities, additional debt transactions/restructuring, future royalty sales, or other strategic transactions, which may include licensing or selling a portion or all of one or more of our existing technologies .
However, pursuing debt financings, certain equity offerings or other strategic transactions may result in mandatory prepayments of the Initial Term Loan to the Credit Agreement.
(See “Note 6 — Debt” for further details).
−Removed: We expect to continue to fund our operations and service our debt for at least the next twelve months with our existing cash and investments.
−Removed: We plan to manage our operating expenses and reduce our cash requirements by reducing or delaying selected research and development efforts and by managing operating expenses.
+Added: If these capital resources, for any reason, are needed but inaccessible, it would have a significantly negative impact on our financial condition.
+Added: For purposes of determining available capital resources, royalty and/or milestone receipts are excluded.
+Added: Should it be necessary, we plan to manage our operating expenses and reduce our projected cash requirements by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities.
+Added: The conditions described above, when evaluated in accordance with the relevant accounting literature, raise substantial doubt with respect to our ability to meet our obligations through November 13, 2025.
Use of Estimates
24 unchanged sentences
Royalties earned are recorded as a reduction to the OMIDRIA contract royalty asset.
+Added: All royalties received from Rayner, other than royalties related to any sales outside the U.S.
+Added: and any royalties received after December 31, 2031, U.S.
+Added: are passed through directly to DRI and are accounted for as interest expense and a reduction of the OMIDRIA royalty obligation.
The amount recorded in discontinued operations in future periods will reflect interest earned on the outstanding OMIDRIA contract royalty asset at 11.0 % and any amounts we receive that are different from the expected royalties.
8 unchanged sentences
To the extent our estimates of future royalties differ materially from previous estimates, we will adjust the carrying amount of the liability for future OMIDRIA royalties to the present value of the revised estimated cash flows, discounted at the implied effective interest rate of 10.27 % utilizing the cumulative catch-up method.
−Removed: The offset to the adjustment would be recognized as a component of net income (loss) from continuing operations (see “Note 8 — OMIDRIA Royalty Obligation”).
+Added: The offset to the adjustment would be recognized as a component of net income (loss) from continuing operations and is recorded as a non-cash adjustment to interest expense (see “Note 8 — OMIDRIA Royalty Obligation”).
Repurchase of 2026 Notes
37 unchanged sentences
The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and investments, and issuers of the investments to the extent recorded on the unaudited condensed consolidated balance sheets.
−Removed: As of June 30, 2024, the Company has no off-balance sheet concentrations of credit risk.
+Added: As of September 30, 2024, the Company has no off-balance sheet concentrations of credit risk.
Note 3 — Net Loss Per Share
Basic net income (loss) per share (“Basic EPS”) is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period.
−Removed: Diluted net income per share (“Diluted EPS”) is computed by dividing net income by the weighted average number of common shares and potentially dilutive common shares outstanding during the period using the treasury stock method.
+Added: Diluted net income (loss) per share (“Diluted EPS”) is computed by dividing net income (loss) by the weighted average number of common shares and potentially dilutive common shares outstanding during the period using the treasury stock method.
We do not compute Diluted EPS for periods in which we have overall net income and a net loss from continuing operations.
1 unchanged sentence
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
2026 Notes convertible to common stock (1)(2)
3 unchanged sentences
Total potentially dilutive shares excluded from net loss per share
−Removed: The 2026 Notes are subject to a capped call arrangements that potentially reduces the dilutive effect of conversion as described in “Note 6 — Debt.” Any potential impact of the capped call arrangements is excluded from this table.
+Added: The 2026 Notes are subject to a capped call arrangements that potentially reduces the dilutive effect of conversion as described in “Note 6 — Debt.” Any potential impact of the capped call arrangement is excluded from this table.
On June 3, 2024, we repurchased $ 118.1 million of our 2026 Notes reducing any effect of dilution related to those notes.
5 unchanged sentences
Interest income is included as a component of other income on our condensed consolidated statement of operations and comprehensive loss.
−Removed: Interest and other income for the three months ended June 30, 2024 and June 30, 2023 consists primarily of interest earned of $ 2.5 million and $ 4.2 million, respectively.
−Removed: Interest and other income for the six months ended June 30, 2024 and June 30, 2023 consists primarily of interest earned of $ 5.3 million and $ 7.6 million, respectively.
+Added: Interest and other income for the three months ended September 30, 2024 and September 30, 2023 consists primarily of interest earned of $ 1.8 million and $ 4.0 million, respectively.
+Added: Interest and other income for the nine months ended September 30, 2024 and September 30, 2023 consists primarily of interest earned of $ 7.1 million and $ 11.7 million, respectively.
The following tables summarize our investments:
−Removed: June 30, 2024
+Added: September 30, 2024
Gross Unrealized
26 unchanged sentences
Our fair value hierarchy for our financial assets and liabilities are as follows:
−Removed: June 30, 2024
+Added: September 30, 2024
(In thousands)
11 unchanged sentences
Total investments
−Removed: Cash held in demand deposit accounts of $ 2.1 million and $ 7.1 million is excluded from our fair-value hierarchy disclosure as of June 30, 2024 and December 31, 2023, respectively.
+Added: Cash held in demand deposit accounts of $ 1.5 million and $ 7.1 million is excluded from our fair-value hierarchy disclosure as of September 30, 2024 and December 31, 2023, respectively.
The carrying amounts reported in the accompanying condensed consolidated balance sheets for receivables, accounts payable and accrued liabilities, and other current monetary assets and liabilities approximate fair value.
3 unchanged sentences
The OMIDRIA contract royalty asset consists of the following:
+Added: September 30,
(In thousands)
4 unchanged sentences
Receivables consist of the following:
+Added: September 30,
(In thousands)
4 unchanged sentences
Property and equipment, net consists of the following:
+Added: September 30,
(In thousands)
5 unchanged sentences
Total property and equipment, net
−Removed: For the three months ended June 30, 2024 and 2023, depreciation and amortization expense was $ 0.2 million and $ 0.3 million, respectively.
−Removed: For the six months ended June 30, 2024 and 2023, depreciation and amortization expense was $ 0.4 million and $ 0.5 million, respectively.
+Added: For the three months ended September 30, 2024 and 2023, depreciation and amortization expense was $ 0.2 million for both periods.
+Added: For the nine months ended September 30, 2024 and 2023, depreciation and amortization expense was $ 0.6 million and $ 0.7 million, respectively.
Accrued Expenses
Accrued expenses consists of the following:
+Added: September 30,
(In thousands)
Clinical trials
−Removed: Contract research and development
Employee compensation
−Removed: Consulting and professional fees
+Added: Contract research and development
Interest payable
+Added: Consulting and professional fees
Other accrued expenses
3 unchanged sentences
On June 3, 2024, we entered into a Credit Agreement with the Lenders, which provides for a term loan credit facility of up to $ 92.1 million, in aggregate, consisting of an Initial Term Loan of $ 67.1 million and a Delayed Draw Term Loan of $ 25.0 million.
−Removed: The Delayed Draw Term Loan may be drawn once in full, on or prior to June 3, 2025, conditioned upon receipt of FDA approval of narsoplimab in TA-TMA.
+Added: The Delayed Draw Term Loan may be drawn once in full upon notice delivered on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the notice.
The Delayed Draw Term Loan would be issued with an original issue discount of 3.0 % and the proceeds may be used only for commercialization of narsoplimab in TA-TMA and transaction costs associated with the Delayed Draw Term Loan.
Until the earlier of November 1, 2025 and the date we elect to utilize the Delayed Draw Term Loan, the Company, at its sole discretion, may exchange up to $ 14.9 million aggregate principal amount of outstanding 2026 Notes for cash and/or additional term loan amounts, with the holders of such notes becoming Lenders under the Credit Agreement (any such additional term loans, together with the Initial Term Loan and the Delayed Draw Term Loan, the “Loans”).
−Removed: As of August 7, 2024, no such additional exchanges have occurred.
+Added: As of November 13, 2024, no such additional exchanges have occurred.
All indebtedness under the Credit Agreement is secured by a first-priority security interest in and lien on substantially all our tangible and intangible property, subject to customary exceptions, and excluding royalty interests in OMIDRIA ® and certain related rights.
1 unchanged sentence
The total consideration paid at closing of $ 88.3 million represents a purchase price equal to approximately 75 % of the par value of the 2026 Notes retired in the transaction.
−Removed: The reduction in the aggregate outstanding principal of balance of our 2026 Notes and incurrence of new Initial Term Loan resulted in a $ 51.0 million reduction of our outstanding debt.
+Added: The reduction in the aggregate outstanding principal balance of our 2026 Notes and incurrence of a new Initial Term Loan resulted in a $ 51.0 million reduction of our outstanding debt.
The $ 29.8 million difference between the $ 118.1 million aggregate principal amount of the 2026 Notes and the $ 88.3 million aggregate repurchase price was recorded as a premium (i.e., an increase) to the long-term debt on the Company’s condensed consolidated balance sheet instead of being recognized as a gain on early extinguishment of debt.
+Added: The premium is being amortized as both a non-cash reduction of long-term debt in the condensed consolidated balance sheets and interest expense in the condensed consolidated statement of operations and comprehensive loss over the duration of the term loan.
As a post-closing adjustment, we accrued $ 0.6 million which was paid in July 2024 in additional cash consideration to a certain Lender.
The amount outstanding on the Initial Term Loan is as follows:
+Added: September 30,
(In thousands)
Principal amount
−Removed: Unamortized debt premium, net of issuance costs
+Added: Unamortized debt premium, net of issuance costs and other
Total long-term debt
The Loans have a stated maturity date of June 3, 2028 and bear interest at an adjusted secured overnight financing rate (“adjusted SOFR”), subject to a 3.0 % floor, plus 8.75 % per annum, payable quarterly from the closing date.
−Removed: As of June 30, 2024, the contractual interest rate on the Loans was 14.20 %.
+Added: As of September 30, 2024, the contractual interest rate on the Loans was 13.87 %.
We have the option to pay all of the interest in cash or to pay 50 % in cash and pay-in-kind (“PIK”), the remaining interest.
4 unchanged sentences
Three Months Ended
+Added: Nine Months Ended
+Added: September 30, 2024
(In thousands)
9 unchanged sentences
(ii) 60.0 % of the net cash proceeds (excluding transaction expenses and certain milestone payments) received by Omeros from the sale or license of our assets (or in the case of an asset sale or license involving narsoplimab that occurs while any Delayed Draw Term Loan is outstanding, an amount equal to 100 % of the net cash proceeds from such transaction);
−Removed: (iii) 100.0% of net cash proceeds of indebtedness incurred by the Company other than as permitted by the Credit Agreement and (iv) 100% of the net cash proceeds of insurance recoveries on loss of property, except to the extent utilized to repair or replace the relevant assets within a specified time.
+Added: (iii) 100.0 % of net cash proceeds of indebtedness incurred by the Company other than as permitted by the Credit Agreement;
+Added: and (iv) 100 % of the net cash proceeds of insurance recoveries on loss of property, except to the extent utilized to repair or replace the relevant assets within a specified time.
Voluntary and mandatory prepayments of the Loans are subject to payment of the following premiums:
2 unchanged sentences
and (iii) during the third year, a prepayment premium equal to 3.0 % of the applicable prepayment amount.
−Removed: The Credit Agreement contains certain customary default provisions, representation and warranties and affirmative and negative covenants.
+Added: The Credit Agreement contains certain customary default provisions, representations and warranties and affirmative and negative covenants.
These include a covenant requiring us to maintain at all times unrestricted cash and cash equivalents of at least $ 25.0 million in accounts subject to control agreements and a covenant limiting the use of cash for open market or privately negotiated repurchases of any outstanding 2026 Notes to:
2 unchanged sentences
and (iii) an additional amount not to exceed 50 % of the net cash proceeds from an equity offering, provided that the Company offers to prepay an equal amount of the Loans with the net cash proceeds of such offering.
−Removed: As of June 30, 2024, the Company was in compliance with the covenants under the Credit Agreement.
−Removed: After review of the customary default provisions, affirmative and negative covenants, and voluntary and mandatory prepayment options, this resulted in a net derivative asset that was not significant as of June 30, 2024.
−Removed: The fair value of the Loans is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market.
−Removed: As of June 30, 2024, the approximate fair value of our Loan obligations was $ 68.9 million.
+Added: As of September 30, 2024, the Company was in compliance with the covenants under the Credit Agreement.
+Added: After review of the customary default provisions, affirmative and negative covenants, and voluntary and mandatory prepayment options, this resulted in a net derivative asset that was not significant as of September 30, 2024.
+Added: The fair value of the Loans is classified as a Level 3 liability.
+Added: As of September 30, 2024, the approximate fair value of our Loan obligations was $ 69.5 million.
We determined the fair market value by discounting the future cash flows based on adjusted SOFR at each measurement date.
1 unchanged sentence
We extinguished the $ 95.0 million outstanding on our 6.25 % convertible senior notes (the “2023 Notes”) at par upon maturity on November 15, 2023.
−Removed: The following table set forth interest expense recognized related to the 2023 Notes.
+Added: The following table sets forth interest expense recognized related to the 2023 Notes.
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
2 unchanged sentences
Amortization of debt issuance costs
−Removed: Total interest expense
2026 Unsecured Convertible Senior Notes
2 unchanged sentences
On June 3, 2024, we completed the 2026 Note Repurchase Transaction, through which we repurchased $ 118.1 million of principal amount outstanding on our 2026 Notes for total consideration of $ 88.3 million (approximately 75 % of par value) , consisting of the Initial Term Loan of $ 67.1 million and $ 21.2 million of cash on hand.
−Removed: As discussed above, subsequent to June 30, 2024, we paid an additional $ 0.6 million in cash to certain Lenders as a post-closing adjustment under the 2026 Note Repurchase Transaction.
+Added: As discussed above, we paid an additional $ 0.6 million in cash in July 2024 to certain Lenders as a post-closing adjustment under the 2026 Note Repurchase Transaction.
Amounts outstanding on our 2026 Notes are as follows:
+Added: September 30,
(In thousands)
6 unchanged sentences
The value of the conversion feature of the 2026 Notes is not deemed to be significant as the current market price of our common stock is below the initial conversion price of $ 18.49 per share of common stock.
−Removed: Unamortized debt issuance costs of $ 1.0 million as of June 30, 2024 are amortized to interest expense at an effective interest rate of 5.89 % over the remaining term.
+Added: Unamortized debt issuance costs of $ 0.8 million as of September 30, 2024 are amortized to interest expense at an effective interest rate of 5.89 % over the remaining term.
The following table sets forth interest expense recognized related to the 2026 Notes:
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
20 unchanged sentences
The Company also retains all potential future value of the capped calls associated with the repurchased 2026 Notes.
−Removed: As of June 30, 2024, approximately 12.2 million shares remained outstanding under the 2026 Capped Call.
+Added: As of September 30, 2024, approximately 12.2 million shares remained outstanding under the 2026 Capped Call.
Further, we concluded the 2026 Capped Call qualifies for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its balance sheet.
1 unchanged sentence
Minimum Commitments
−Removed: As of June 30, 2024, the most probable principal payments on our 2026 Notes and Term Loan are as follows.
+Added: As of September 30, 2024, the most probable principal payments on our 2026 Notes and Term Loan are as follows.
(In thousands)
1 unchanged sentence
Total principal payments
−Removed: Unamortized premiums, discounts and issuance costs
+Added: Unamortized premiums, discounts and issuance costs and other
Carrying value of debt
5 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
8 unchanged sentences
Remeasurement adjustments
−Removed: OMIDRIA contract royalty asset at June 30, 2024
+Added: OMIDRIA contract royalty asset at September 30, 2024
We remeasure the OMIDRIA contract royalty asset on a quarterly basis using the expected value approach, which incorporates actual results and future expectations.
Cash flow from discontinued operations is as follows:
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(In thousands)
1 unchanged sentence
Net cash provided by discontinued operations primarily represents royalties received and the $ 200.0 million milestone payment that we collected from Rayner in February 2023.
+Added: All royalties earned on OMIDRIA sales within the U.S.
+Added: through December 31, 2031 are remitted by Rayner to DRI via an escrow arrangement.
Note 8 — OMIDRIA Royalty Obligation
8 unchanged sentences
DRI has no recourse to our assets other than its interest in OMIDRIA royalties.
−Removed: We are also entitled to receive a milestone ranging between $ 10.0 million and $ 27.5 million if U.S.
+Added: We are also entitled to receive a milestone payment ranging between $ 10.0 million and $ 27.5 million if U.S.
net sales of OMIDRIA reach applicable thresholds ranging between a total of $ 156.0 million and $ 160.0 million for any period of four consecutive quarters prior to January 1, 2026.
−Removed: In addition, we are entitled to receive a separate milestone ranging between $ 8.0 million and $ 27.5 million if U.S.
+Added: In addition, we are entitled to receive a separate milestone payment ranging between $ 8.0 million and $ 27.5 million if U.S.
net sales of OMIDRIA reach applicable thresholds ranging between a total of $ 181.0 million and $ 185.0 million for any period of four consecutive quarters prior to January 1, 2028.
The following schedule is a roll forward of the OMIDRIA royalty obligation (in thousands):
−Removed: OMIDRIA royalty obligation at December 31, 2023
+Added: Balance at December 31, 2023
Additional proceeds
1 unchanged sentence
Principal payments
−Removed: OMIDRIA royalty obligation at June 30, 2024
+Added: Balance at September 30, 2024
We account for the OMIDRIA royalty obligation under the catch-up method.
3 unchanged sentences
The OMIDRIA royalty obligation is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market.
−Removed: As of June 30, 2024, the approximate fair value of our obligation was $ 216.9 million .
−Removed: We determined the fair market value by discounting the future cash flows based on the initial contractual rate adjusted for any changes in the prime rate through to the measurement date.
−Removed: For the three months ended June 30, 2024 and 2023, we incurred interest expense of $ 6.4 million and $ 3.0 million, respectively.
−Removed: For the six months ended June 30, 2024 and 2023, we incurred interest expense of $ 11.5 million and $ 5.9 million, respectively.
−Removed: As of June 30, 2024, future expected principal and interest payments are as follows:
+Added: As of September 30, 2024, the approximate fair value of our obligation was $ 213.4 million .
+Added: We determined the fair market value by discounting the estimated future cash flows based on the initial contractual rate adjusted for any changes in the prime rate through to the measurement date.
+Added: For the three months ended September 30, 2024 and 2023, we incurred interest expense of $ 2.2 million and $ 3.0 million, respectively.
+Added: For the nine months ended September 30, 2024 and 2023, we incurred interest expense of $ 13.7 million and $ 8.9 million, respectively.
+Added: As of September 30, 2024, future expected principal and interest payments are as follows:
(In thousands)
6 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
5 unchanged sentences
Cash paid for amounts included in the measurement of lease liabilities is as follows:
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(In thousands)
4 unchanged sentences
Good and Service Contracts
−Removed: We have various agreements with third parties that collectively require payment of termination fees totaling $ 7.9 million as of June 30, 2024 if we cancel the work within specific time frames, either prior to commencing or during performance of the contracted services.
+Added: We have various agreements with third parties that collectively require payment of termination fees totaling $ 5.6 million as of September 30, 2024 if we cancel the work within specific time frames, either prior to commencing or during performance of the contracted services.
Development Milestones and Product Royalties
1 unchanged sentence
Some of these agreements require milestone payments based on achievements of development, regulatory or sales milestones, and/or low-single to low-double digit royalties on net income or net sales of the relevant product.
−Removed: For the three and six months ended June 30, 2024 and 2023, development milestone expenses were not significant.
+Added: For the three and nine months ended September 30, 2024, development milestone expenses were not significant.
+Added: In the three and nine months ended September 30, 2023, we paid a third-party licensor $ 5.0 million in connection with achievement of a development milestone in our zaltenibart program.
Note 11 — Shareholders ’ Equity (Deficit)
At the Market Sales Agreement - We have a sales agreement to sell shares of our common stock having an aggregate offering price of up to $ 150.0 million, from time to time, through an “at the market” equity offering program.
−Removed: As of June 30, 2024, we have not sold any shares under this program.
+Added: As of September 30, 2024, we have not sold any shares under this program.
Share Repurchase Program - On November 9, 2023, the Board of Directors approved an indefinite term share repurchase program under which we were authorized to repurchase from time to time up to $ 50.0 million of our common stock in the open market or through privately negotiated transactions.
1 unchanged sentence
During the first quarter of 2024, we repurchased and retired 3.2 million shares of common stock at an average share price of $ 3.71 at an aggregate cost of $ 11.9 million.
−Removed: We did not repurchase any shares of our common stock in the three months ended June 30, 2024.
The terms of the Credit Agreement prohibit us from repurchasing our common stock unless expressly agreed to by the Lenders.
4 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
9 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
−Removed: June 30, 2024
−Removed: June 30, 2024
+Added: Nine Months Ended
+Added: September 30, 2024
+Added: September 30, 2024
Estimated weighted-average fair value
13 unchanged sentences
Balance at December 31, 2023
−Removed: Balance at June 30, 2024
−Removed: Vested and expected to vest at June 30, 2024
−Removed: Exercisable at June 30, 2024
+Added: Balance at September 30, 2024
+Added: Vested and expected to vest at September 30, 2024
+Added: Exercisable at September 30, 2024
On April 25, 2024, annual stock option grants of approximately 2.9 million shares of common stock were awarded to eligible participants for the 2023 annual performance period.
−Removed: Of the 18.0 million common stock options outstanding as of June 30, 2024, 9.8 million have an exercise price per share above $ 4.06 , which was the closing price of our stock on the Nasdaq exchange on June 28, 2024.
−Removed: As of June 30, 2024, there were 6.4 million unvested options outstanding that will vest over a weighted-average period of 2.5 years.
+Added: Of the 18.1 million common stock options outstanding as of September 30, 2024, 9.8 million have an exercise price per share above $ 3.97 , which was the closing price of our stock on the Nasdaq exchange on September 30, 2024.
+Added: As of September 30, 2024, there were 6.0 million unvested options outstanding that will vest over a weighted-average period of 2.4 years.
The total estimated compensation expense yet to be recognized on outstanding options is $ 14.4 million.
−Removed: As of June 30, 2024, the total number of shares of common stock available for grant was 6.1 million.
+Added: As of September 30, 2024, the total number of shares of common stock available for grant was 5.9 million.
+Added: As of October 29, 2024, the total number of shares of common stock available for grant increased to 7.1 million due to approximately 1.2 million shares of common stock expiring and returning to our stock option plan for reissuance.
MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
1 unchanged sentence
In addition, you should read the section entitled “ Risk Factors ” and the disclaimers regarding forward-looking statements included herein and in our Annual Report on Form 10-K for the year ended December 31, 2023, for a discussion of important factors that could cause our results to differ materially from the results described in or implied by any forward-looking statements contained herein.
−Removed: Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders.
+Added: Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders.
Complement Inhibitor Programs
10 unchanged sentences
Importantly, inhibition of MASP-2 has been demonstrated not to interfere with the antibody-dependent classical complement activation pathway, a critical component of the acquired immune response to infection.
−Removed: The lead drug candidate in our pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting MASP-2, the key activator of the lectin pathway of complement.
+Added: The lead product candidate in our pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting MASP-2, the key activator of the lectin pathway of complement.
Clinical development of narsoplimab is currently focused primarily on hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”).
2 unchanged sentences
We appealed FDA’s decision to issue the CRL through a formal dispute resolution process that concluded in late 2022.
−Removed: Although our appeal was denied, the decision identified potential paths for resubmission of the BLA based on both response data and survival data from the completed pivotal trial versus a historical control group, with or without an independent literature analysis or based on survival data alone.
−Removed: Consistent with subsequent interactions with FDA’s review division, we submitted to FDA an analysis plan to assess already existing clinical trial data, existing data from a historical control population available from an external source, data from the narsoplimab expanded access program, and data directed to the mechanism of action of narsoplimab.
−Removed: We are having ongoing discussions with the agency regarding the proposed analysis plan and FDA's requirements for resubmission of our BLA.
−Removed: As a result, we are currently unable to estimate when we will submit the BLA or, subsequently, FDA’s timing for a decision regarding approval.
−Removed: There can be no guarantee that FDA’s specific recommendations for resubmission will be acceptable to us in terms of the time and/or expenditure required or that any resubmission of the BLA will result in approval of narsoplimab for TA-TMA.
+Added: Although our appeal was denied, the decision identified potential paths for resubmission of the BLA, including paths based on comparison of survival data from the completed pivotal trial versus a historical control group.
+Added: Consistent with subsequent interactions with FDA’s review division, we previously submitted to FDA an analysis plan to assess already existing clinical trial data, existing data from a historical control population available from an external source, data from the narsoplimab expanded access program, and data directed to the mechanism of action of narsoplimab.
+Added: As a part of our most recent meeting with FDA, in September 2024, we received minor feedback on our proposed statistical analysis plan for the primary endpoint – patient survival in our pivotal narsoplimab trial compared to that in an external registry of TA-TMA patients – which was a limited request to include certain additional sensitivity analyses.
+Added: Additional sensitivity analyses were quickly incorporated into the plan and sent back to FDA.
+Added: FDA’s reply is expected in November 2024.
+Added: We have no other information requests pending and are not aware of any other impediment to resubmitting our narsoplimab BLA.
+Added: After receiving FDA’s response and, assuming general alignment on the revised plan, we intend to proceed with conducting the primary and secondary efficacy analyses.
+Added: If the results support resubmission, then we intend to finalize and resubmit our BLA as soon as possible.
+Added: We are currently unable to provide a specific estimate of when or if we will resubmit the BLA or, subsequently, FDA’s timing for a decision regarding approval.
+Added: Even if the results of the efficacy analysis are favorable and FDA accepts our resubmitted BLA for review, there can be no guarantee that FDA will approve narsoplimab for TA-TMA.
Additionally, there is strong and increasingly well-established evidence of the central role of the lectin pathway in COVID-19 and acute respiratory distress syndrome (“ARDS”), and we have developed mechanistic, in vivo animal data, and proof-of-concept clinical data indicating that narsoplimab may be an effective therapeutic for COVID-19, ARDS and/or related indications.
7 unchanged sentences
We have completed Phase 1 clinical trials evaluating both single-ascending and multiple-ascending doses of OMS1029.
−Removed: Results of these studies support once-quarterly dosing, administered either intravenously or subcutaneously.
+Added: Results of these studies confirmed by pharmacokinetic and pharmacodynamic modeling and dose simulation, support once-quarterly, low-volume dosing, administered either intravenously or subcutaneously.
OMS1029 has been well tolerated to date with no safety concerns identified.
−Removed: We continue to evaluate several potential indications for Phase 2 clinical development for OMS1029.
+Added: We continue to evaluate several potential indications for which Phase 2 clinical development of OMS1029 could be pursued, depending on resource availability.
Alternative Pathway / MASP-3
−Removed: Our pipeline of clinical-stage complement-targeted therapeutic candidates also includes OMS906, now known as a “zaltenibart,” a proprietary, patented monoclonal antibody targeting MASP-3, the key activator of the alternative pathway of complement.
−Removed: We believe OMS906 has the potential to treat a wide range of alternative pathway-related diseases and that its attributes favorably differentiate OMS906 from other marketed and in-development alternative pathway inhibitors.
−Removed: The United States Adopted Names (“USAN”) Council, in consultation with the World Health Organization’s International Nonproprietary Names (“INN”) Expert Committee, has recently adopted for OMS906 the nonproprietary name “zaltenibart.” The USAN Council, by working closely with the INN Programme of the World Health Organization and various national nomenclature groups, aims for global standardization and unification of drug nomenclature to ensure that drug information is communicated accurately and unambiguously.
−Removed: Going forward, we will use the name zaltenibart in publications, at conferences and in other forums to refer to our lead MASP-3 antibody.
+Added: Our pipeline of clinical-stage complement-targeted therapeutic candidates also includes zaltenibart (previously designated as OMS906), a proprietary, patented monoclonal antibody targeting MASP-3, the key activator of the alternative pathway of complement.
+Added: We believe zaltenibart has the potential to treat a wide range of alternative pathway-related diseases and that its attributes favorably differentiate zaltenibart from other marketed and in-development alternative pathway inhibitors.
Clinical development of zaltenibart is currently focused on rapidly advancing to Phase 3 clinical trials in multiple alternative pathway-related disorders, including paroxysmal nocturnal hemoglobinuria (“PNH”) and complement 3 glomerulopathy (“C3G”).
We have multiple ongoing Phase 2 clinical trials evaluating zaltenibart in these indications.
−Removed: We have one ongoing Phase 1 study in healthy subjects that is evaluating higher doses than were used in the completed Phase 1 study.
−Removed: We also have three ongoing Phase 2 clinical trials evaluating zaltenibart for PNH.
−Removed: The first is in PNH patients who have not previously been treated with a complement inhibitor and the second in PNH patients who have had an unsatisfactory response to ravulizumab, an inhibitor of complement component 5 (“C5”).
−Removed: The third Phase 2 clinical trial is an open-label extension study to assess the long-term efficacy and safety of zaltenibart in patients who have completed either of the other two PNH Phase 2 clinical trials.
−Removed: The ongoing Phase 1 study has successfully dosed subjects at two different dose levels, and data from this study have provided important pharmacokinetic (“PK”) and pharmacodynamic (“PD”) information for determination of final dosing for our Phase 3 trials.
−Removed: Results from a pre-specified interim analysis of our ongoing Phase 2 clinical trial of zaltenibart in complement-inhibitor-naïve adults with PNH were featured in a podium presentation at the annual meeting of the American Society of Hematology in December 2023.
+Added: Wehave three ongoing clinical trials evaluating zaltenibart for PNH.
+Added: The first is in PNH patients who have not previously been treated with a complement inhibitor, and the second is in PNH patients who have had an unsatisfactory response to ravulizumab, an inhibitor of complement component 5 (“C5”).
+Added: The third clinical trial evaluating zaltenibart in PNH is an open-label extension study to assess the long-term efficacy and safety of zaltenibart in patients who have completed either of the other two PNH clinical trials.
+Added: Results from a pre-specified interim analysis of our ongoing clinical trial of zaltenibart in complement-inhibitor-naïve adults with PNH were featured in a podium presentation at the annual meeting of the American Society of Hematology in December 2023.
The interim analysis results showed statistically significant and clinically meaningful improvements in all measured markers of hemolysis, including hemoglobin and lactate dehydrogenase.
This study was amended to gather additional data to inform the choice of zaltenibart dose for Phase 3 development.
−Removed: These data have been collected and are being analyzed.
−Removed: Enrollment is complete and dosing is ongoing in our Phase 2 trial evaluating two doses of zaltenibart in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab.
−Removed: Utilizing a “switch-over” design, this study enrolls PNH patients receiving ravulizumab, adds zaltenibart to provide combination therapy with ravulizumab for 24 weeks, and then, in those patients who demonstrate a hemoglobin response with the combination therapy, switches to zaltenibart monotherapy.
+Added: With these data, along with data from our Phase 1 study in healthy subjects evaluating higher dose levels than were used in our first completed Phase 1 study, we have now finalized selection of the zaltenibart dose for Phase 3 development.
+Added: Zaltenibart has been well tolerated to date with no safety concerns identified.
+Added: The last patient visit in our Phase 2 trial evaluating two doses of zaltenibart in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab occurred in October 2024.
+Added: Utilizing a “switch-over” design, this study enrolled PNH patients receiving ravulizumab, added zaltenibart to provide combination therapy with ravulizumab for 24 weeks, and then, in those patients who demonstrated a hemoglobin response with the combination therapy, switched to zaltenibart monotherapy.
In June 2024, efficacy data from a pre-specified interim analysis of the combination therapy portion of the trial were featured in a podium presentation at the annual congress of the European Hematology Association held in Madrid, Spain.
−Removed: The interim analysis showed that the addition of zaltenibart therapy to ravulizumab treatment resulted in statistically significant and clinical meaningful improvements in both mean hemoglobin levels and absolute reticulocyte counts by week 4 of combination therapy, with a sustained response demonstrated through week 24 (the latest assessment prior to the interim analysis cutoff).
+Added: The interim analysis showed that the addition of zaltenibart therapy to ravulizumab treatment resulted in statistically significant and clinical meaningful improvements in both mean hemoglobin levels and absolute reticulocyte counts by week 4 of combination therapy, with a sustained response observed through week 24 (the latest assessment prior to the interim analysis cutoff).
All 13 enrolled patients were included in the interim analysis.
All patients in the high-dose group achieved clinical response, defined as an increase in hemoglobin of at least 2 grams, and six of seven patients in the low-dose group achieved this same clinical response.
−Removed: Interim analysis data from the monotherapy portion of the trial showed that clinically meaningful improvements in hemoglobin levels and absolute reticulocyte counts were sustained following transition to zaltenibart monotherapy and prevented both intra-vascular and extra-vascular hemolysis.
+Added: Data from the monotherapy portion of the trial show that clinically meaningful improvements in hemoglobin levels and absolute reticulocyte counts were sustained following transition to zaltenibart monotherapy and prevented both intravascular and extravascular hemolysis.
As with all other clinical studies with zaltenibart, the drug was well tolerated without any safety signal of concern.
−Removed: Full details from the interim analysis in the monotherapy portion of the trial are expected to be presented at a relevant scientific congress in late 2024.
−Removed: We have initiated an open-label extension study to assess the long-term efficacy and safety of zaltenibart in patients with PNH.
+Added: Full details from interim analysis in the monotherapy portion of the trial will be presented at the annual meeting of the American Society of Hematology in December 2024.
+Added: Our third Phase 2 study is an open-label extension study to assess the long-term efficacy and safety of zaltenibart in patients with PNH.
In the extension study, PNH patients who have completed a previous study evaluating zaltenibart roll directly into the extension study without a break in zaltenibart treatment.
−Removed: Data from this study will contribute to a planned BLA for zaltenibart in the treatment of PNH.
−Removed: Selection of the dose level and frequency for the Phase 3 studies and commercialization, if approved, is being informed by PK data from the two Phase 1 single-ascending-dose studies of zaltenibart in healthy subjects and interim data from our ongoing clinical trials in PNH patients.
−Removed: In February 2024, we met with FDA to discuss our development program for zaltenibart in PNH.
−Removed: We presented clinical and nonclinical data and requested input on expectations for Phase 3 studies and BLA submission.
−Removed: FDA confirmed that the scope of our nonclinical program is sufficient to support Phase 3 clinical studies and provided input on dosing and design of the proposed Phase 3 program to support a BLA in PNH.
−Removed: We expect to meet again with FDA as well as European regulators later this year to discuss further details of our planned Phase 3 studies.
−Removed: Phase 3 clinical trials evaluating zaltenibart in PNH are targeted to begin in late 2024.
+Added: Data from this study are expected to contribute to any future marketing applications for zaltenibart in the treatment of PNH.
+Added: As with our Phase 2 program, our Phase 3 development program in PNH is anticipated to include both a “switch-over” study and a study treating patients who are not receiving a complement-inhibitor.
+Added: In September and October 2024, we met with FDA and European regulators to discuss further details of our planned Phase 3 program for zaltenibart in PNH.
+Added: With both regulatory agencies, we discussed data developed from our clinical and nonclinical programs to date and our Phase 3 development plans for zaltenibart in PNH.
+Added: Both regulatory agencies agreed with the design of our proposed studies, as well as our dose-finding strategy, and provided other valuable feedback to inform our development plans.
+Added: The Phase 3 protocols are being finalized and we expect to open enrollment in our Phase 3 program evaluating zaltenibart in PNH in early 2025.
We also have an ongoing Phase 2 clinical program evaluating zaltenibart for the treatment of C3G, a rare and debilitating renal disease driven by complement dysregulation.
−Removed: Notably, the relevance of the alternative pathway to C3G has been clinically validated in a Phase 3 trial with another inhibitor of the alternative pathway that reported positive results in the treatment of C3G.
−Removed: Sites are now open in multiple countries and enrollment has begun.
−Removed: We are targeting to initiate Phase 3 development for C3G in the first quarter of 2025.
+Added: Notably, the relevance of the alternative pathway to C3G has been clinically validated in two Phase 3 trials with other inhibitors of the alternative pathway that reported positive results in the treatment of C3G.
+Added: Sites for the zaltenibart Phase 2 trial in C3G are open to enrollment in multiple countries and dosing in the study is ongoing.
+Added: We are targeting to initiate Phase 3 trials for C3G in the first half of 2025.
+Added: In October, we announced that zaltenibart received a rare pediatric disease designation from FDA for the treatment of C3G.
+Added: Companies awarded a rare pediatric disease designation are eligible to receive a rare pediatric disease priority review voucher from FDA when the designated drug's first approval is for the associated indication in the pediatric population and certain other criteria are met.
+Added: Absent expected legislative reauthorization and extension of the priority review voucher program for rare pediatric disease, one of the criteria under current law is that the drug be approved by September 30, 2026.
+Added: The holder of a priority review voucher is entitled to obtain a priority review by FDA of either a new drug application or a biologics license application for a different product and/or indication, reducing the review time and accelerating any grant of approval and subsequent market entry by at least four months.
+Added: The voucher may be used by the original recipient, or it can be sold for use by another company.
PDE7 Inhibitor Programs
4 unchanged sentences
The preclinical study is intended to provide the toxicology data necessary to support the human study of OMS527 in CUD.
−Removed: The toxicology study is underway and is expected to be completed in late 2024.
−Removed: Immuno-Oncology Platform
−Removed: We have five immuno-oncology (“I-O”) platforms in preclinical development - adoptive T-cell therapy, CAR-T, signaling-driven immunomodulators that function both as therapeutics and vaccines, and oncotoxins.
−Removed: To date, in vitro , ex vivo and animal studies using human cellular components have been positive with high response rates.
−Removed: These data collectively reinforce the scientific basis for each platform, confirming our rationale for their design and development.
−Removed: The data from our studies to date have demonstrated a number of potential advantages of our immuno-oncology franchise over other I-O approaches.
−Removed: We believe that all five platforms are entirely novel and proprietary.
−Removed: We continue to confirm our results and to generate new data, all of which contribute to our intellectual property position.
+Added: The toxicology study is underway and is expected to be completed by the end of 2024.
+Added: Assuming positive results, we expect enrollment in the study evaluating OMS527 in adults patients with CUD to begin in 2025, also fully funded by NIDA.
+Added: Oncology Platform
+Added: Building on our understanding of immunity, both innate, or complement-mediated, and adaptive, meaning B-cells as well as CD4 and CD8 T-cells, the objective of our oncology program is to move beyond existing targeted biologics, such as antibody-drug conjugates and radioligands, and beyond immuno-therapies, like checkpoint inhibitors and CAR-T.
+Added: To achieve this, we are developing a portfolio of signaling-driven immunomodulators, oncotoxins, and an adoptive T-cell technology combined with an immunostimulator that, unlike other cellular therapy approaches requires no cellular engineering, reduces manufacturing costs and timelines, and maintains an enhanced anti-cancer immune response through subsequent repetitive and simple therapeutic administrations.
+Added: We believe that the in vitro and in vivo study data generated to date support the potential of our novel therapeutic programs to deliver effective and safe cancer therapies that can overcome the shortcomings of currently marketed therapies by:
+Added: ● treating both hematological and solid tumors;
+Added: ● targeting both cell-surface and intracellular cancer antigens;
+Added: ● increasing levels of CD4 and CD8 cancer antigen-specific effector and memory cells.
+Added: Our oncology development program is operating in stealth mode as we continue to confirm our results and to generate new data which we expect will contribute to our intellectual property position.
+Added: We expect to share additional details regarding our oncology programs in coming months, after the relevant intellectual property filings have been completed.
OMIDRIA Sale and Royalty Monetization Transactions
26 unchanged sentences
payable from and after January 1, 2024, as well as all royalties on global net sales of OMIDRIA payable from and after December 31, 2031.
+Added: To date, international royalties have not been significant, but are expected to increase in 2025.
+Added: DRI has no recourse to our assets other than its interest in OMIDRIA royalties.
In addition to the cash consideration received at closing, the DRI Amendment also entitles us to receive two milestone payments of up to $27.5 million each, payable in January 2026 and January 2028, respectively, based on achievement of certain thresholds for U.S.
3 unchanged sentences
On June 3, 2024 (the “Closing Date”), we, with certain subsidiaries, as guarantors, entered into a Credit and Guaranty Agreement (the “Credit Agreement”) with certain funds managed by Athyrium Capital Management, LP (collectively, “Athyrium”) and certain funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”) as lenders (together with additional lenders from time to time, the “Lenders”) and Wilmington Savings Fund Society, FSB, as administrative agent and collateral agent.
−Removed: The Credit Agreement provides for a senior secured term loan facility initially of up to $92.1 million consisting of (i) an initial term loan of $67.1 million (the “Initial Term Loan”), which was fully funded on the Closing Date, and (ii) a $25.0 million delayed draw term loan (the “Delayed Draw Term Loan”), which may be drawn once in full on or prior to June 3, 2025, provided that the we have received FDA approval of narsoplimab in TA-TMA.
+Added: The Credit Agreement provides for a senior secured term loan facility initially of up to $92.1 million consisting of (i) an initial term loan of $67.1 million (the “Initial Term Loan”), which was fully funded on the Closing Date, and (ii) a $25.0 million delayed draw term loan (the “Delayed Draw Term Loan”), which may be drawn once in full upon notice delivered on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the notice.
Proceeds of the Delayed Draw Term Loan, if borrowed, must be used to fund the commercialization of narsoplimab and to pay transaction costs associated with the Delayed Draw Term Loan.
4 unchanged sentences
We paid accrued and unpaid interest on the repurchased 2026 Notes through the Closing Date.
−Removed: As of June 30, 2024, we accrued $0.6 million in post-closing adjustments to certain Lenders and paid them in July 2024.
+Added: In July 2024, we paid $0.6 million in post-closing adjustments to certain Lenders.
We are permitted under the Credit Agreement to repurchase additional outstanding 2026 Notes for cash in open market or privately negotiated transactions, subject to certain limitations described below.
22 unchanged sentences
Financial Summary
−Removed: Our loss for the three and six months ended June 30, 2024 was $56.0 million and $93.2 million, respectively.
−Removed: As of June 30, 2024, we had cash, cash equivalents and short-term investments of $158.9 million available to fund operations and to service debt.
+Added: Our loss for the three and nine months ended September 30, 2024 was $32.2 million and $125.5 million, respectively.
+Added: As of September 30, 2024, we had cash, cash equivalents and short-term investments of $123.2 million available to fund operations and to service debt.
Results of Operations
4 unchanged sentences
and stock-based compensation expense.
−Removed: Direct external expenses consist primarily of expenses incurred pursuant to agreements with third-party manufacturing organizations prior to receiving regulatory approval for a drug candidate, contract research organizations, clinical trial sites, collaborators, licensors and consultants.
−Removed: Pre-clinical research and development includes costs prior to beginning Phase 1 studies in human subjects.
+Added: Direct external expenses consist primarily of expenses incurred pursuant to agreements with third-party manufacturing organizations prior to receiving regulatory approval for a product candidate, contract research organizations, clinical trial sites, collaborators, licensors and consultants.
+Added: Preclinical research and development includes costs prior to beginning Phase 1 studies in human subjects.
Internal overhead and other expenses primarily consist of costs for personnel, overhead, rent, utilities and depreciation.
+Added: Our accounting policy is to expense all manufacturing costs related to product candidates until regulatory approval is reasonably assured in either the U.S.
+Added: or European Union.
The following table illustrates our expenses associated with these activities:
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
11 unchanged sentences
Total research and development expenses
−Removed: For the three and six months ended June 30, 2024, clinical research and development expenses increased $14.7 million and $14.9 million, respectively, compared to the prior year periods.
−Removed: The increases were primarily due to increased narsoplimab drug substance manufacturing and zaltenibart clinical research costs, partially offset by decreased clinical expenditures on narsoplimab due to the termination of our IgA nephropathy program following analysis of our Phase 3 clinical trial results .
−Removed: Our accounting policy is to expense all manufacturing costs related to drug candidates until regulatory approval is reasonably assured in either the U.S.
−Removed: or European Union.
−Removed: For the three and six months ended June 30, 2024, internal overhead and other expenses increased $0.8 million and $2.3 million, respectively, as compared to the same periods in the prior year.
−Removed: The increases were primarily due to additional employee related costs and receipt of an Employee Retention Credit received in the second quarter of the prior year that was recorded as an offset to expense.
−Removed: Stock-based compensation expenses decreased $0.3 million for the six months ended June 30, 2024 as compared to the same period in the prior year, primarily due to the valuation and timing of the vesting of employee stock options.
−Removed: We expect research and development expenses in the third quarter of 2024 to be substantially lower than those in the second quarter of this year primarily due to the manufacturing costs associated with narsoplimab that were expensed in the second quarter.
−Removed: At this time, we are unable to estimate with certainty the longer-term costs we will incur in the continued development of our drug candidates due to the inherently unpredictable nature of our preclinical and clinical development activities.
+Added: For the three months ended September 30, 2024, clinical research and development expenses decreased $8.5 million compared to the prior year quarter primarily due to the wind down of our IgA nephropathy program following analysis of our Phase 3 clinical trial results.
+Added: In addition, in the prior year quarter, we paid a third-party licensor $5.0 million in connection with achievement of a development milestone in our zaltenibart program.
+Added: For the nine months ended September 30, 2024, clinical research and development expenses increased $6.5 million compared to the same period in the prior year primarily due to increased narsoplimab drug substance manufacturing and zaltenibart clinical research costs, partially offset by decreased costs due to the closeout of our IgA nephropathy program and payment in the prior year to a third-party licensor of the above-mentioned zaltenibart achievement milestone.
+Added: Preclinical research and development costs increased $1.5 million for the nine months ended September 30, 2024 primarily due to increased expenses associated with our immune-oncology platforms.
+Added: Internal overhead and other expenses increased $2.8 million for the nine months ended September 30, 2024 primarily due to additional employee related costs and having received an Employee Retention Credit in the prior year that was recorded as an offset to expense.
+Added: Stock-based compensation expenses decreased $0.2 million and $0.6 million for the three and nine months ended September 30, 2024, respectively, as compared to the same periods in the prior year, primarily due to the valuation and timing of the vesting of employee stock options.
+Added: We expect research and development expenses in the fourth quarter of 2024 to be similar to those in the third quarter of this year.
+Added: At this time, we are unable to estimate with certainty the longer-term costs we will incur in the continued development of our product candidates due to the inherently unpredictable nature of our preclinical and clinical development activities.
Clinical development timelines, the probability of success and development costs can differ materially as new data become available and as expectations change.
−Removed: Our future research and development expenses will depend, in part, on the preclinical or clinical success of each drug candidate as well as ongoing assessments of each program’s commercial potential.
−Removed: In addition, we cannot forecast with precision which drug candidates, if any, may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
−Removed: We are required to expend substantial resources in the development of our drug candidates due to the lengthy process of completing clinical trials and seeking regulatory approval.
+Added: Our future research and development expenses will depend, in part, on the preclinical or clinical success of each product candidate as well as ongoing assessments of each program’s commercial potential.
+Added: In addition, we cannot forecast with precision which product candidates, if any, may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
+Added: We are required to expend substantial resources in the development of our product candidates due to the lengthy process of completing clinical trials and seeking regulatory approval.
Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could delay our generation of product revenue and increase our research and development expenses.
1 unchanged sentence
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
3 unchanged sentences
Total selling, general and administrative expenses
−Removed: For the three and six months ended June 30, 2024, selling, general and administrative expenses, excluding stock-based compensation expense, increased $2.5 million and $3.8 million, respectively, as compared to the same periods in the prior year.
−Removed: The increase was primarily due to legal and financial advisory expenses incurred in the connection with the 2026 Note Repurchase Transaction, receipt of an Employee Retention Credit in the second quarter of 2023 ( that was recorded as an offset to expense) and patent related expenses.
−Removed: We expect selling, general and administrative expenses in the third quarter of 2024 to be lower compared to those in the second quarter of this year.
+Added: For the three and nine months ended September 30, 2024, selling, general and administrative expenses, excluding stock-based compensation expense, decreased $4.6 million and $0.9 million, respectively, as compared to the same periods in the prior year.
+Added: The decreases were primarily due to a non-recurring employee compensation expense in the prior year period and reduced marketing spend in the current year associated with the closeout of our IGA nephropathy program.
+Added: For the nine months ended September 30, 2024, these decreases were partially offset by additional spend on legal patents.
+Added: We expect selling, general and administrative expenses in the fourth quarter of 2024 to be similar to those in the third quarter of this year.
Interest Expense
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
Interest expense
−Removed: Interest expense is primarily comprised of interest and amortization of debt discount and issuance costs on our 2026 Notes as well as interest on our DRI royalty obligation (see “Note 6 — Debt ” and “Note 8 — OMIDRIA Royalty Obligation” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q).
−Removed: Interest expense for the three and six months ended June 30, 2024 increased $1.3 million and $1.6 million, respectively, due to a $115.5 million of borrowing under our royalty obligation with DRI in February 2024.
−Removed: These increases were partially offset by a reduction in interest expense from the retirement at maturity in November 2023 of our 6.25% convertible senior notes, which had a par value of $95.0 million, and the partial repurchase of our 2026 Notes in December 2023 and in June 2024, which had a collective par value of $127.2 million.
−Removed: We expect that interest expense for the third quarter of 2024 will decrease from the second quarter due to the net reduction of debt resulting from the 2026 Note Repurchase Transaction.
+Added: Interest expense is comprised of interest and amortization of debt discount and issuance costs on our Initial Term Loan, 2026 Notes as well as interest on our DRI royalty obligation (see “Note 6 — Debt” and “Note 8 — OMIDRIA Royalty Obligation” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q).
+Added: Interest expense for the three and nine months ended September 30, 2024 decreased $3.9 million and $2.3 million, respectively, primarily due to retirement at maturity in November 2023 of our 6.25% convertible senior notes, which had a par value of $95.0 million.
+Added: For the nine months ended September 30, 2024, interest expense also decreased due to the partial repurchase of our 2026 Notes in December 2023 and June 2024, which had a collective par value of $127.2 million.
+Added: The decrease was partially offset by an increase in interest expense related to the OMIDRIA Royalty Obligation with DRI and interest under our Credit Agreement.
+Added: We expect that interest expense for the fourth quarter of 2024 will increase from the third quarter due to the higher interest associated with the OMIDRIA Royalty Obligation.
Interest and Other Income
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
Interest and other income
−Removed: Interest and other income decreased $1.3 million and $1.8 million for the three and six months ended June 30, 2024, respectively, as compared to the same periods in 2023 primarily due to holding a lower average cash and investment balance than in the prior year.
−Removed: We expect interest and other income for the third quarter of 2024 to be lower compared to those in the second quarter of this year due to lower average cash and investment balances.
−Removed: Discontinued operations and OMIDRIA contract royalty asset
+Added: Interest and other income decreased $2.1 million and $3.9 million for the three and nine months ended September 30, 2024, respectively, as compared to the same periods in 2023 primarily due to holding a lower average cash and investment balance than in the prior year.
+Added: Included with other income for the current year is our grant from NIDA for which we have recognized $0.8 million in the nine months ended September 30, 2024.
+Added: We expect interest and other income for the fourth quarter of 2024 to be lower compared to those in the third quarter of this year due to lower average cash and investment balances.
+Added: Discontinued operations and the OMIDRIA contract royalty asset
Net income from OMIDRIA discontinued operations, net of tax is shown below:
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
+Added: September 30,
(In thousands)
4 unchanged sentences
Interest is earned on the OMIDRIA contract royalty asset at an implied effective interest rate of 11.0%.
−Removed: The $0.4 million and $0.9 million increase in interest earned for the three and six months ended June 30, 2024, respectively, were due to a higher OMIDRIA contract royalty asset balance in 2024 than during the same periods in 2023.
−Removed: The increased balance in the OMIDRIA contract royalty asset resulted from periodic remeasurements made during 2023.
−Removed: For the three and six months ended June 30, 2024, remeasurement adjustments increased $1.2 million and $1.8 million, respectively, reflecting the increased interest incurred on the OMIDRIA contract royalty asset as a result of remeasurements made during 2023.
+Added: The $0.5 million and $1.3 million increase in interest earned for the three and nine months ended September 30, 2024, respectively, were due to a higher OMIDRIA contract royalty asset balance in 2024 than during the same periods in 2023.
+Added: The increased balance in the OMIDRIA contract royalty asset resulted from periodic remeasurements made during 2023 and 2024.
+Added: For the three and nine months ended September 30, 2024, remeasurement adjustments decreased $9.4 million and $7.5 million, respectively.
+Added: The decreases reflect a reduced rate of increase in the estimated future royalty payments in 2024 than in 2023.
The following schedule presents a roll forward of the OMIDRIA contract royalty asset (in thousands):
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Remeasurement adjustments
−Removed: OMIDRIA contract royalty asset at June 30, 2024
+Added: OMIDRIA contract royalty asset at September 30, 2024
Financial Condition – Liquidity and Capital Resources
−Removed: As of June 30, 2024, we had cash, cash equivalents and short-term investments of $158.9 million.
−Removed: Our loss for the three and six months ended June 30, 2024 was $56.0 million and $93.2 million, respectively.
−Removed: Cash used in operations for the six months ended June 30, 2024 was $87.8 million.
−Removed: The second quarter of 2024 includes a $17.6 million charge for delivery of narsoplimab drug substance.
−Removed: In addition, we made a $21.2 million payment for term loan-related debt repurchase and incurred $1.9 million of term loan-related transaction costs.
+Added: As of September 30, 2024, we had cash, cash equivalents and short-term investments of $123.2 million.
+Added: Our loss for the three and nine months ended September 30, 2024 was $32.2 million and $125.5 million, respectively.
+Added: Cash used in operations for the nine months ended September 30, 2024 was $119.8 million, which includes an $18.4 million charge for delivery of narsoplimab drug substance and a $21.2 million payment related to our 2026 Note Repurchase Transaction.
Pursuant to a covenant in the Credit Agreement entered on June 3, 2024, we must maintain at all times unrestricted cash and cash equivalents of at least $25.0 million.
−Removed: Historically, we have incurred net losses from continuing operations and negative operating cash flows.
−Removed: We have not yet established an ongoing source of revenue sufficient to cover our operating costs;
−Removed: therefore, we potentially need to continue to raise additional capital to accomplish our business plan.
−Removed: We have a sales agreement to sell shares of our common stock, from time to time, in an “at the market” equity offering facility through which we may offer and sell shares of our common stock equaling an aggregate amount up to $150.0 million.
−Removed: In addition, our Delayed Draw Term Loan of $25.0 million may be drawn once in full on or prior to June 3, 2025 at our election, but it is conditioned on the approval by FDA of narsoplimab in TA-TMA.
−Removed: Proceeds of the Delayed Draw Term Loan may only be used toward any related transaction costs and for commercialization efforts of TA-TMA.
+Added: In recent years, Omeros has incurred net losses from continuing operations and negative cash flows from operations.
+Added: The recurring losses, in combination with our cash and investment balances as of September 30, 2024, and an expected repayment of a portion of our outstanding debt on or prior to November 2025, raise substantial doubt about our ability to continue as a going concern for the twelve-month period ending November 13, 2025.
+Added: As we currently do not have an ongoing source of revenue sufficient to cover our operating costs, we will need to raise additional capital to accomplish our business plan.
+Added: We have a sales agreement to sell shares of our common stock, from time to time, in an "at the market" equity offering facility through which we may offer and sell shares of our common stock equaling an amount up to $150.0 million.
+Added: In addition, our Delayed Draw Term Loan of $25.0 million may be drawn once in full upon notice delivered on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the notice.
+Added: Proceeds of the Delayed Draw Term Loan may only be used towards any related transaction costs and for commercialization of narsoplimab efforts of TA-TMA.
We may pursue additional debt financings to retire the 2026 Notes that remain outstanding and to fund operations.
−Removed: Should it be determined to be strategically advantageous, we could pursue public and private offerings of our equity securities, or other strategic transactions, which may include licensing or selling a portion or all of one or more of our existing technologies.
+Added: Should it be necessary or determined to be strategically advantageous, we also could pursue public and private offerings of our equity securities, additional debt transactions/restructuring, future royalty sales, or other strategic transactions, which may include licensing or selling a portion or all of one or more of our existing technologies.
However, pursuing debt financings, certain equity offerings or other strategic transactions may result in mandatory prepayments of the Initial Term Loan to the Credit Agreement.
−Removed: (See “Note 6 — Debt” for further details).
−Removed: We expect to continue to fund our operations and service our debt for at least the next twelve months with our existing cash and investments.
−Removed: We plan to manage our operating expenses and reduce our cash requirements by reducing or delaying selected research and development efforts and by managing operating expenses.
+Added: (See “Note 6 — Debt” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for details).
+Added: If these capital resources, for any reason, are needed but inaccessible, it would have a significantly negative impact on our financial condition.
+Added: For purposes of determining available capital resources, royalty and/or milestone receipts are excluded.
+Added: Should it be necessary, we plan to manage our operating expenses and reduce our projected cash requirements by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities.
Cash Flow Data
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(In thousands)
5 unchanged sentences
Operating Activities.
−Removed: Net cash used in operating activities for the six months ended June 30, 2024 increased by $230.0 million compared to the same period in 2023 .
−Removed: This change was primarily due to collecting a $200.0 million Milestone Payment from Rayner in the prior year, a $22.2 million increase in net loss, a $9.1 million decrease in accounts payable and accrued expenses, and a $2.9 million decrease in prepaid expenses.
+Added: Net cash used in operating activities for the nine months ended September 30, 2024 increased by $229.4 million compared to the same period in 2023.
+Added: This change was primarily due to collecting a $200.0 million Milestone Payment from Rayner in the prior year, the 2024 net loss increasing by $16.7 million, and accounts payable and accrued expenses decreasing by $15.0 million in the current year.
Investing Activities.
2 unchanged sentences
As we manage our usage with respect to total cash, cash equivalents and short-term investments, we do not consider fluctuations in cash flows from investing activities to be important to the understanding of our liquidity and capital resources.
−Removed: Net cash provided by investing activities during the six months ended June 30, 2024 increased by $157.2 million as compared to the same period in 2023.
−Removed: The increase was due to the timing of purchasing investments and of maturities of investments.
+Added: Net cash provided by investing activities during the nine months ended September 30, 2024 increased by $136.1 million as compared to the same period in 2023.
+Added: The increase was due to the timing of investment maturities and purchases.
Significant initial investment purchases during the periods were the investment of the $200.0 million Milestone Payment we received from Rayner in February 2023 and the $115.5 million we received from DRI related to the sale of future OMIDRIA royalties in February 2024.
Financing Activities.
−Removed: Net cash provided by financing activities during the six months ended June 30, 2024 increased $72.2 million compared to the same period in 2023.
−Removed: The increase was primarily due to receiving the $115.5 million related to the sale of future OMIDRIA royalties in February 2024 from DRI offset by $10.7 million of principal payments on the OMIDRIA royalty obligation.
−Removed: Additionally, we paid $21.2 million to the Lenders in the 2026 Note Repurchase Transaction and repurchased 3.2 million shares of our common stock for $11.9 million.
+Added: Net cash provided by financing activities during the nine months ended September 30, 2024 increased $68.1 million compared to the same period in 2023.
+Added: The increase was primarily due to receiving the $115.5 million related to the sale of future OMIDRIA royalties in February 2024 from DRI.
+Added: This was offset by $21.2 million we paid in 2024 for the 2026 Note Repurchase Transaction, a $14.3 million increase in 2024 principal payments paid to DRI on the OMIDRIA royalty obligation and $11.9 million paid in 2024 to repurchase 3.2 million shares of our common stock.
Contractual Obligations and Commitments
6 unchanged sentences
In addition, we carry various finance lease obligations for laboratory and office equipment.
−Removed: As of June 30, 2024, the remaining aggregate non-cancelable rent payable under the initial term of the lease, excluding common area maintenance and related operating expenses, is $23.4 million.
+Added: As of September 30, 2024, the remaining aggregate non-cancelable rent payable under the initial term of the lease, excluding common area maintenance and related operating expenses, is $20.8 million.
Convertible Senior Notes and Long-Term Debt
7 unchanged sentences
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.