EX-99.1 2 d835519dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

XOMA Royalty Reports Third Quarter 2024 Financial Results

and Highlights Recent Activities

Zevra’s MIPLYFFA (arimoclomol) received FDA approval and became the sixth commercial asset in XOMA Royalty’s portfolio

XOMA Royalty acquired a 50 percent economic interest in TWIST Bioscience’s portfolio of 60-plus

licensed early-stage assets across approximately 30 partners

Cash receipts totaled $9.9 million in the third quarter, and $42.3 million for the first nine months of 2024

EMERYVILLE, Calif. – November 7, 2024 (GLOBE NEWSWIRE) – XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its third quarter 2024 financial results and highlighted recent activities.

“We continue to take a balanced approach to building a portfolio of sustainable cashflow streams by selectively acquiring royalty economics across the lifecycle of drug development,” stated Owen Hughes, Chief Executive Officer of XOMA Royalty. “The September approval of MIPLYFFA, the first therapy approved for patients living with Niemann-Pick disease Type C, adds to our growing commercial royalty portfolio, while the recent transaction with Twist Bioscience further expands our early-stage portfolio, a key focus for us as we look to distribute risk across a diversified portfolio.”

Key Third Quarter Events

 

Partner

  

Event

Zevra Therapeutics    The U.S. Food and Drug Administration (FDA) approved Zevra’s MIPLYFFA (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC). MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.
Rezolute   

Announced the sunRIZE Phase 3 clinical trial investigating ersodetug (RZ358) in patients with congenital hyperinsulinism (CHI) will begin enrolling patients in the U.S. in early 20251.

 

Received FDA clearance to initiate Phase 3 registrational study for ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism2.

 

1 

https://ir.rezolutebio.com/news/detail/339/fda-lifts-partial-clinical-holds-on-rz358-for-the-treatment-of-congenital-hyperinsulinism-and-
authorizes-u-s-inclusion-in-ongoing-phase-3-study

2 

https://ir.rezolutebio.com/news/detail/337/rezolute-announces-fda-clearance-of-ind-application-for-phase-3-registrational-study-of-rz358-
for-treatment-of-hypoglycemia-due-to-tumor-hyperinsulinism


Johnson & Johnson    Presented neoadjuvant TAR-200 plus cetrelimab Phase 2 data in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and are scheduled for radical cystectomy at the European Society of Medical Oncology 2024 Congress3.

Subsequent Events

 

Partner

  

Event

Twist Bioscience    XOMA Royalty completed a $15 million royalty monetization agreement with Twist, acquiring 50% of the future milestones and royalties and adding 60-plus partnered early-stage programs across 30 companies enabled by Twist Bioscience’s Biopharma Solutions business unit to the XOMA Royalty portfolio.
Johnson & Johnson    Announced one of two Phase 3 clinical trials in difficult to treat muscle-invasive bladder cancer (MIBC) that included treatment with cetrelimab was being discontinued for not showing superiority to chemoradiation during a scheduled interim analysis4. Cetrelimab continues to be investigated in multiple other clinical trials.

Anticipated 2024 Events of Note

 

Partner

  

Event

Takeda    On December 12, 2024, Takeda will be hosting an R&D Day: Focus on Late-State Pipeline and Market Opportunity and has commented publicly mezagitamab will be discussed during this investor event.

Third Quarter 2024 Financial Results

XOMA Royalty recorded total income and revenues of $7.2 million for the third quarter of 2024, which included $6.5 million in estimated income associated with two commercial products in our portfolio. In the third quarter of 2023, XOMA Royalty reported total income and revenue of $0.8 million.

Research and development (R&D) expenses were $0.8 million in the third quarter of 2024, reflecting transitory clinical trial costs related to KIN-3248, an asset acquired in the Kinnate acquisition, which the Company currently is winding down. R&D expenses in the third quarter of 2023 were $25,000.

 

 

3 

https://www.jnj.com/media-center/press-releases/neoadjuvant-tar-200-plus-cetrelimab-nearly-doubles-the-pathological-complete-response-
rate-compared-to-cetrelimab-alone-in-patients-with-muscle-invasive-bladder-cancer

4 

https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-the-sunrise-2-study


General and administrative (“G&A”) expenses were $8.0 million for the third quarter of 2024 compared with $6.4 million in the third quarter of 2023. The increase of $1.6 million was primarily comprised of $1.4 million in total costs incurred after our acquisition of Kinnate, which included $1.1 million in legal and consulting costs, $0.1 million in information technology costs, and $0.1 million in insurance costs. The remainder of the increased G&A expense reflects an increase of $0.2 million for salaries and related costs.

In the third quarter of 2024, as a result of communications with Agenus, XOMA Royalty evaluated the status of the partnered programs underlying the Agenus Royalty Purchase Agreement for potential impairment and recorded a one-time, non-cash impairment charge of $14.0 million and a reduction of royalty receivables of $14.0 million associated with Agenus.

In the third quarters of 2024 and 2023, G&A expenses included $2.6 million and $2.7 million, respectively, in non-cash stock-based compensation expenses.

Total interest expense in the third quarter of 2024 was $3.5 million, representing interest and costs related to the Blue Owl Loan established in December 2023.

The Company reported total other income, net, of $1.9 million in the third quarter of 2024, as compared to total other income, net, of $0.3 million in the corresponding period of 2023. The $1.6 million increase reflects a $1.3 million increase in investment income due to higher balances on our investments and the change in the market price for XOMA Royalty’s shares of Rezolute common stock.

Net loss for the third quarter of 2024 was $17.2 million, compared to a net loss of $5.5 million for the third quarter of 2023, primarily resulting from the $14.0 million non-cash impairment related to the Agenus Royalty Purchase Agreement.

On September 30, 2024, XOMA Royalty had cash and cash equivalents of $146.8 million (including $4.8 million in restricted cash). On December 31, 2023, XOMA Royalty had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). During the third quarter of 2024, XOMA Royalty received $9.9 million in cash from royalty and commercial payments. Net cash used in operating activities during the quarter was $8.6 million. On October 15, 2024, the Company paid a total of $1.4 million in cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO).

About XOMA Royalty Corporation

XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow XOMA Royalty Corporation on LinkedIn.


Forward-Looking Statements/Explanatory Notes

Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA Royalty and other developments related to VABYSMO® (faricimab-svoa), OJEMDA (tovorafenib), MIPLYFFA (arimoclomol), XACIATO (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet); the potential occurrences of the events listed under “Anticipated 2024 Events of Note”; the anticipated timings of regulatory filings and approvals related to assets in XOMA Royalty’s portfolio; and the potential of XOMA Royalty’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA Royalty’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; and if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them. Other potential risks to XOMA Royalty meeting these expectations are described in more detail in XOMA Royalty’s most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA Royalty’s prospects. Any forward-looking statement in this press release represents XOMA Royalty’s beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA Royalty disclaims any obligation to update any forward-looking statement, except as required by applicable law.

EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development.

As of the date of this press release, the commercial assets in XOMA Royalty’s milestone and royalty portfolio are VABYSMO® (faricimab-svoa), OJEMDA (tovorafenib), MIPLYFFA (arimoclomol), XACIATO (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet). All other assets in the milestone and royalty portfolio are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available.


XOMA ROYALTY CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2024     2023     2024     2023  

Income and revenues:

        

Income from purchased receivables

   $ 6,463     $ —      $ 11,895     $ —   

Revenue from contracts with customers

     25       225       6,050       1,350  

Revenue recognized under units-of-revenue method

     709       605       1,828       1,575  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total income and revenues

     7,197       830       19,773       2,925  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Research and development

     817       25       2,011       118  

General and administrative

     8,020       6,368       27,485       18,341  

Royalty purchase agreement asset impairment

     14,000       —        23,000       1,575  

Arbitration settlement costs

     —        —        —        4,132  

Amortization of intangible assets

     —        224       —        673  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     22,837       6,617       52,496       24,839  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (15,640     (5,787     (32,723     (21,914

Other income (expense):

        

Gain on the acquisition of Kinnate

     —        —        19,316       —   

Change in fair value of embedded derivative related to RPA

     —        —        8,100       —   

Interest expense

     (3,493     —        (10,446     —   

Other income (expense), net

     1,890       278       5,900       1,192  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (17,243   $ (5,509   $ (9,853   $ (20,722
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders, basic

   $ (18,611   $ (6,877   $ (13,957   $ (24,826
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net loss per share attributable to common stockholders

   $ (1.59   $ (0.60   $ (1.20   $ (2.17
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares used in computing basic net loss per share attributable to common stockholders

     11,712       11,473       11,645       11,466  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders, diluted

   $ (18,611   $ (6,877   $ (13,957   $ (24,826
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted net loss per share attributable to common stockholders

   $ (1.59   $ (0.60   $ (1.20   $ (2.17
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares used in computing diluted net loss per share attributable to common stockholders

     11,712       11,473       11,645       11,466  
  

 

 

   

 

 

   

 

 

   

 

 

 


XOMA ROYALTY CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

 

     September 30,
2024
    December 31,
2023
 
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 142,050     $ 153,290  

Short-term restricted cash

     80       160  

Short-term equity securities

     785       161  

Trade and other receivables, net

     1,045       1,004  

Short-term royalty and commercial payment receivables

     12,682       14,215  

Prepaid expenses and other current assets

     2,379       483  
  

 

 

   

 

 

 

Total current assets

     159,021       169,313  

Long-term restricted cash

     4,686       6,100  

Property and equipment, net

     34       25  

Operating lease right-of-use assets

     335       378  

Long-term royalty and commercial payment receivables

     54,207       57,952  

Exarafenib milestone asset

     3,125       —   

Other assets - long term

     1,932       533  
  

 

 

   

 

 

 

Total assets

   $ 223,340     $ 234,301  
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 1,131     $ 653  

Accrued and other liabilities

     2,451       2,768  

Contingent consideration under RPAs, AAAs, and CPPAs

     4,000       7,000  

Operating lease liabilities

     434       54  

Unearned revenue recognized under units-of-revenue method

     1,924       2,113  

Preferred stock dividend accrual

     1,368       1,368  

Current portion of long-term debt

     9,826       5,543  
  

 

 

   

 

 

 

Total current liabilities

     21,134       19,499  

Unearned revenue recognized under units-of-revenue method – long-term

     5,589       7,228  

Exarafenib milestone contingent consideration

     3,125       —   

Long-term operating lease liabilities

     594       335  

Long-term debt

     108,089       118,518  
  

 

 

   

 

 

 

Total liabilities

     138,531       145,580  
  

 

 

   

 

 

 

Stockholders’ equity:

    

Preferred Stock, $0.05 par value, 1,000,000 shares authorized:

    

8.625% Series A cumulative, perpetual preferred stock, 984,000 shares issued and outstanding at September 30, 2024 and December 31, 2023

     49       49  

8.375% Series B cumulative, perpetual preferred stock, 1,600 shares issued and outstanding at September 30, 2024 and December 31, 2023

     —        —   

Convertible preferred stock, 5,003 issued and outstanding at September 30, 2024 and December 31, 2023

     —        —   

Common stock, $0.0075 par value, 277,333,332 shares authorized, 11,755,223 and 11,495,492 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

     88       86  

Additional paid-in capital

     1,317,657       1,311,809  

Accumulated other comprehensive income

     104       —   

Accumulated deficit

     (1,233,089     (1,223,223
  

 

 

   

 

 

 

Total stockholders’ equity

     84,809       88,721  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 223,340     $ 234,301  
  

 

 

   

 

 

 


XOMA ROYALTY CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

     Nine Months Ended
September 30,
 
     2024     2023  

Cash flows from operating activities:

    

Net loss

   $ (9,853   $ (20,722

Adjustments to reconcile net loss to net cash used in operating activities:

    

Income from purchased receivables under effective interest rate method

     (9,985     —   

Stock-based compensation expense

     8,136       6,450  

Royalty purchase agreement asset impairment

     23,000       1,575  

Gain on the acquisition of Kinnate

     (19,316     —   

Change in fair value of contingent consideration under RPAs, AAAs, and CPPAs

     —        (75

Common stock contribution to 401(k)

     118       123  

Amortization of intangible assets

     —        673  

Depreciation

     8       2  

Accretion of long-term debt discount and debt issuance costs

     996       —   

Non-cash lease expense

     45       115  

Change in fair value of equity securities

     (624     121  

Change in fair value of available-for-sale debt securities classified as cash equivalents

     104       —   

Changes in assets and liabilities:

    

Trade and other receivables, net

     (41     (42

Prepaid expenses and other assets

     (72     (202

Accounts payable and accrued liabilities

     (1,348     (554

Operating lease liabilities

     (185     (120

Unearned revenue recognized under units-of-revenue method

     (1,828     (1,575
  

 

 

   

 

 

 

Net cash used in operating activities

     (10,845     (14,231
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Net cash acquired in Kinnate acquisition

     18,926       —   

Payments of consideration under RPAs, AAAs, and CPPAs

     (37,000     (14,650

Receipts under RPAs, AAAs, and CPPAs

     26,263       8,428  

Purchase of property and equipment

     (17     —   
  

 

 

   

 

 

 

Net cash provided by (used in) investing activities

     8,172       (6,222
  

 

 

   

 

 

 

Cash flows from financing activities:

    

Principal payments —  debt

     (6,902     —   

Debt issuance costs and loan fees paid in connection with long-term debt

     (740     —   

Payment of preferred stock dividends

     (4,104     (4,104

Repurchases of common stock

     (13     —   

Proceeds from exercise of options and other share-based compensation

     4,127       208  

Taxes paid related to net share settlement of equity awards

     (2,429     (5
  

 

 

   

 

 

 

Net cash used in financing activities

     (10,061     (3,901
  

 

 

   

 

 

 

Net decrease in cash, cash equivalents, and restricted cash

     (12,734     (24,354

Cash, cash equivalents, and restricted cash as of the beginning of the period

     159,550       57,826  
  

 

 

   

 

 

 

Cash, cash equivalents, and restricted cash as of the end of the period

   $ 146,816     $ 33,472  
  

 

 

   

 

 

 

Supplemental Cash Flow Information:

    

Cash paid for interest

   $ 9,985     $ —   

Right-of-use assets obtained in exchange for operating lease liabilities

   $ —      $ 85  

Non-cash investing and financing activities:

    

Estimated initial fair value of the Exarafenib milestone asset in Kinnate acquisition

   $ 2,922     $ —   

Estimated initial fair value of the Exarafenib milestone contingent consideration in Kinnate acquisition

   $ 2,922     $ —   

Right-of-use assets obtained in exchange for operating lease liabilities in Kinnate acquisition

   $ 824     $ —   

Relative fair value basis reduction of right-of-use assets in Kinnate acquisition

   $ (824   $ —   

Accrual of contingent consideration under the Affitech CPPA

   $ 3,000     $ 3,000  

Accrual of contingent consideration under the LadRx AAA

   $ 1,000       —   

Estimated fair value of contingent consideration under the LadRx Agreements

   $ —      $ 1,000  

Preferred stock dividend accrual

   $ 1,368     $ 1,368  


# # #

 

Investor contact:

  

Media contact:

Juliane Snowden    Kathy Vincent
XOMA Royalty Corporation    KV Consulting & Management
+1-646-438-9754    +1-310-403-8951
juliane.snowden@xoma.com    kathy@kathyvincent.com