On February 26, 2025 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, reported business highlights and financial results for the fourth quarter and full year of fiscal year 2024, ended November 30, 2024 (Press release, Theratechnologies, FEB 26, 2025, View Source [SID1234650642]). All figures are in U.S. dollars unless otherwise stated.

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Fourth-Quarter and Fiscal 2024 Revenue Highlights

(in 000s of US$)

Three-month
periods ended

November 30,

%
change Years ended
November 30, %
change

2024 2023 2024 2023

EGRIFTA SV net sales

17,674 16,958 4.2 % 60,147 53,705 12.0 %
Trogarzo net sales

7,328 6,494 12.8 % 25,719 28,059 (8.3 %)

Revenue

$ 25,002 $ 23,452 6.6 % $ 85,866 $ 81,764 5.0 %

*This is a non-IFRS measure. See "non-IFRS and non-U.S. GAAP measure" below.

"Fourth quarter of 2024 marked a standout finish to the year, generating $25 million in revenue and leading to annual revenue of $85.9 million," said Paul Lévesque, President and Chief Executive Officer. "Our bottom line was even stronger, delivering a positive Adjusted EBITDA for the quarter of $7.8 million, up 56% over fourth quarter of 2023 and a full year result surpassing $20 million in Adjusted EBITDA, as compared to negative $3 million in 2023. Our financial success was rewarded by $75 million in new credit facilities with TD Bank and Investissement Québec, highlighting confidence in our longer-term growth strategy, which is to strengthen and scale our commercial business underpinned by our HIV portfolio. We witnessed unprecedented demand for EGRIFTA SV this past year resulting in full-year sales of $60.1 million dollars, which represents 12% growth year-over-year. We will continue to manufacture additional batches of EGRIFTA SV until the anticipated transition to the F8 formulation.

Lévesque added, "The addition of olezarsen and donidalorsen in Canada are expected to drive long-term growth over and above our foundational HIV business. I am equally confident that our team’s demonstrated experience and expertise in commercializing treatments in the US and Canada will enable us to deliver on additional assets with new and existing partners. In parallel, we are actively searching for a partner for our oncology program to continue the important evaluation of our novel PDCs. With an FDA protocol amendment in hand to pursue the Phase 1 trial at higher doses and a comprehensive preclinical and clinical data set, we believe we can find the right partner to continue this important science."

Recent Company Highlights

Remediation to Temporary Supply Disruption for EGRIFTA SV

On January 9, 2025, the Company announced a temporary supply disruption for EGRIFTA SV caused by an unexpected voluntary shutdown of the Company’s contract manufacturer’s facility in 2024, following an inspection by the United States Food and Drug Administration ("FDA"). The manufacturer has resumed manufacturing of EGRIFTA SV in November 2024. In order to resume distribution of EGRIFTA SV, the Company was required to file a Prior Approval Supplement ("PAS") with the FDA describing the changes made by its manufacturer. The Company filed the PAS, which is subject to a four month review period, on December 18, 2024.

On February 13, 2025, the FDA, via its Drug Shortage Staff, indicated that it would allow the Company to sell and distribute newly manufactured batches of EGRIFTA SV while the review of the PAS is ongoing, thereby allowing the Company to sell two manufactured batches of EGRIFTA SV, representing up to six months of supply. Distribution of the product resumed on February 13, 2025.

In its communication of February 13, 2025, the FDA indicated that if the Company plans to submit a new or updated proposal to continue mitigating this shortage beyond these two batches, the Company should submit the shortage mitigation proposal to the Drug Shortage Staff so that the FDA can evaluate the proposal. The Company’s contract manufacturer has already manufactured one additional batch of EGRIFTA SV, and two additional batches are planned before the end of the third quarter of 2025.

Theratechnologies Receives March 2025 PDUFA Action Date for Updated Tesamorelin F8 Formulation sBLA

On December 10, 2024, the Company announced that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 25, 2025 to the Company’s supplemental Biologics License Application for the F8 formulation of tesamorelin ("F8 Formulation"), submitted on November 26, 2024. If approved by the FDA, the F8 Formulation is intended to replace the F4 formulation, which is sold in the U.S. under the trade name EGRIFTA SV. The F8 Formulation is patent protected in the U.S. until 2033.

Company Secures up to $75 Million in New Credit Facilities with TD Bank and Investissement Québec

On December 2, 2024, the Company announced that it had closed on a $40 million three-year non-dilutive, senior secured syndicated financing with TD Bank, as agent (TD Bank Financing). This new credit facility includes a $15 million revolving credit facility, and a term loan totaling $25 million. The credit facility also includes a $20 million accordion feature, which could expand total commitments up to $60 million. Investissement Québec (IQ), the Company’s largest shareholder, has also agreed to provide a $15 million second ranking secured subordinated term loan (IQ Subordinated Loan). Net proceeds from the new loans together with cash on hand were used to repay all obligations, including prepayment penalties, under the Company’s existing facility with affiliates of Marathon Asset Management, L.P. ("Marathon") pursuant to the credit agreement entered into with Marathon in July 2022 (the "Marathon Credit Agreement"), and to fund the $10 million upfront consideration associated to the Ionis product licenses.

Exclusive Licensing Agreement with Ionis to Commercialize Olezarsen and Donidalorsen in Canada

On December 4, 2024, the Company announced it entered into an agreement with Ionis Pharmaceuticals, Inc. ("Ionis") to in-license two investigational RNA-targeted medicines developed by Ionis. Under the agreement, Theratechnologies receives exclusive rights in Canada for olezarsen, which is being evaluated for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG), and for donidalorsen, which is being evaluated for the treatment of hereditary angioedema (HAE).

Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology

On December 9, 2024, the Company announced preliminary efficacy and safety data from Part 3 (dose escalation, weekly dosing schedule) of its Phase 1b trial of sudocetaxel zendusortide (TH1902), the Company’s lead investigational peptide drug conjugate (PDC) in patients with advanced ovarian cancer. Based on results demonstrating favorable tolerability and signals of efficacy, the Medical Review Committee, which includes study investigators and external experts, has unanimously recommended continued evaluation and exploration of higher doses. On January 31, 2025, the Company received FDA approval to proceed with an amendment to its Phase 1 study protocol to increase the dose of sudocetaxel zendusortide on the same weekly infusion cycle to 3.33 followed by 3.90 mg/kg/wk.

The Company is currently reaching out to pharmaceuticals companies to out-license the rights to sudocetaxel zendusortide and to its SORT1+ TechnologyTM platform.

Summary of Financial Results

The financial results presented in this press release are taken from the Company’s Management’s Discussion and Analysis ("MD&A"), and audited consolidated financial statements ("Audited Financial Statements") for the twelve-month period ended November 30, 2024, or Fiscal 2024, which have been prepared in accordance with International Financial Reporting Standards ("IFRS"), as issued by the International Accounting Standards Board ("IASB"). The MD&A and the Audited Financial Statements can be found SEDAR+ at www.sedarplus.ca, on EDGAR at www.sec.gov and at www.theratech.com. Unless specified otherwise, all capitalized terms have the meaning ascribed thereto in our MD&A.

Fourth-Quarter Fiscal 2024 Financial Results

Revenue

Consolidated revenue for the three months ended November 30, 2024, amounted to $25,002,000 compared to $23,452,000 for the same period last year, representing an increase of 6.6%.

For the fourth quarter of Fiscal 2024, sales of EGRIFTA SV reached $17,674,000 compared to $16,958,000 in the fourth quarter of the prior year, representing an increase of 4.2%. Revenue growth for EGRIFTA SV is mostly related to increased unit sales (+4.2%) and a higher selling price (+5%), and was hampered by higher government chargeback and rebates (-1.5%).

In the fourth quarter of Fiscal 2024, Trogarzo sales amounted to $7,328,000 compared to $6,494,000 for the same quarter of Fiscal 2023, representing an increase of 12.8%. The increase was mainly due to higher unit sales (+11.2%) in the quarter as compared to last year, as well as a higher selling price (+3.4%) and was hampered by higher government chargeback and rebates (-1.8%).

Cost of Sales

In the fourth quarter of Fiscal 2024, cost of sales was $6,096,000 compared to $5,066,000 for the same period in Fiscal 2023.

Cost of Sales

Three months

ended November 30

2024 2023
($000s) % of
Revenue ($000s) % of
Revenue
EGRIFTA SV

2,289 13.0 % 1,713 10.1 %
Trogarzo

3,807 52.0 % 3,353 51.6 %
Total

6,096 24.4 % 5,066 21.6 %
For the three-month period ended November 30, 2024, EGRIFTA SV cost of sales was negatively affected by a $661,000 inventory provision ($50,000 in the comparable period of 2023) related to the manufacturing of a batch of F8 Formulation, as the F8 Formulation has not yet been approved by the FDA for commercialization. No such provision was taken in the three-month period ended November 30, 2023. Trogarzo cost of sales is contractually established at 52% of net sales, subject to periodic adjustment for returns or other factors.

R&D Expenses

R&D expenses in the fourth quarter of Fiscal 2024 amounted to $5,884,000 compared to $5,229,000 in the comparable period of Fiscal 2023. R&D expenses were higher because of the impairment loss on intangible assets related to our oncology program ($3,488,000). This increase was offset by the reduction in other R&D expenses in the three-month period ended November 30, 2024, and were further reduced by the recognition of Canadian federal non-refundable tax credits ($838,000).

R&D expenses in the fourth quarter of Fiscal 2024 were negatively impacted by an impairment loss of the intangible asset of $3,488,000 related to the acquisition of our oncology program. We recorded no such impairment in the three-month period ended November 30, 2023.

Selling Expenses

Selling expenses in the three-month period ended November 30, 2024, amounted to $7,044,000 compared to $6,748,000 in the comparable period of Fiscal 2023, an increase of 4.4%.

The increase in selling expenses is largely associated with the overall growth of the commercial operations, in-line with the strategic goal of ensuring continued top-line revenue growth.

The amortization of the intangible asset value for the EGRIFTA SV and Trogarzo commercialization rights is also included in selling expenses. As such, we recorded amortization expense of $360,000 for the three-month period ended November 30, 2024 unchanged as compared to the same period of Fiscal 2023.

General and Administrative Expenses

General and administrative expenses in the fourth quarter of Fiscal 2024 amounted to $5,059,000, compared to $3,739,000 reported in the same period of Fiscal 2023. The increase in General and administrative expenses is mainly due to higher stock based compensation expense.

Adjusted EBITDA

Adjusted EBITDA was $7,756,000 for the fourth quarter of Fiscal 2024, compared to $4,958,000 for the same period of Fiscal 2023. See "Non-IFRS and Non-US-GAAP Measure" below and see "Reconciliation of Adjusted EBITDA" below for a reconciliation to Net Loss for the relevant periods.

Net Finance Costs

Net finance costs for the three-month period ended November 30, 2024, were $7,801,000 compared to $5,352,000 in the same period of last year. The increase in net finance costs is due to the higher interest expense on the Marathon Loan Facility, as well as the higher loss on long-term debt modifications and repayment related to the repayment of the Marathon Loan Facility.

Income Tax Expense

Income tax expense amounted to $1,021,000, versus $73,000 in the same period last year. The increase in the fourth quarter of 2024 over the same period of 2023 is attributable to the higher net fiscal income generated by our operations. The Company recorded Canadian federal non-refundable tax credits in the three-month period ended November 30, 2024 ($838,000) against research and development expenses, which largely offsets the Canadian federal income tax payable. Refer to Note 20 of the Audited Financial Statements.

Net Loss

Taking into account the revenue and expense variations described above, the Company recorded a net loss of $7,903,000, or $0.16 per share, in the fourth quarter of Fiscal 2024 compared to a net loss of $2,755,000, or $0.08 per share, in the fourth quarter of Fiscal 2023.

Fiscal Year 2024 Financial Results compared to Fiscal Year 2023 Financial Results

Revenue

Consolidated revenue for Fiscal 2024 was $85,866,000 compared to $81,764,000 for the same period last year, representing an increase of 5.0%.

For Fiscal 2024, sales of EGRIFTA SV reached $60,147,000 compared to $53,705,000 for the same period last year representing growth of 12%. The increase in net sales of EGRIFTA SV was mostly the result of a higher number of units sold compared to the previous year (+9.0%), as well as a higher selling price (+5.6%) and were hampered by higher government chargebacks and rebates (-2.6%). Overall growth of EGRIFTA SV unit sales was hampered in Q1 2024 by draw downs in inventory at specialty pharmacies, a situation which has now been normalized.

In Fiscal 2024, Trogarzo net sales were $25,719,000 compared to $28,059,000 in the prior year, a decrease of 8.3%. Lower sales of Trogarzo were mostly the result of lower unit sales due to competitive pressures in the multidrug-resistant segment of the HIV-1 market, where Trogarzo remains an important part of the treatment arsenal but has lost market share to market leaders in the segment. We foresee less of an impact from new entrants in the future. The decrease is explained by a lower number of units sold compared to the previous year (-11.4%) and was mitigated by a higher selling price (+3.7%). The remaining difference is explained by lower sales in Europe, which were minimal since we decided to cease selling efforts in Europe in 2022.

Cost of Sales

For Fiscal 2024, cost of sales was $20,448,000 compared to $19,635,000 in Fiscal 2023.

Cost of Sales

Fiscal Year

ended November 30

2024 2023
($000s) % of
Revenue ($000s) % of
Revenue
EGRIFTA SV

7,190 12.0 % 4,998 9.3 %
Trogarzo

13,258 51.5 % 14,637 52.2 %
Total

20,448 23.8 19,635 24.0 %
For Fiscal 2024, EGRIFTA SV cost of sales was negatively affected by a $1,749,000 inventory provision ($220,000 in Fiscal 2023) related to the manufacturing of a batch of F8 Formulation, as the F8 Formulation has not yet been approved by the FDA for commercialization. Trogarzo cost of sales is contractually established at 52% of net sales, subject to periodic adjustment for returns or other factors.

R&D Expenses

R&D expenses were $16,973,000 for Fiscal 2024 compared to $30,370,000 for Fiscal 2023, a decrease of 44.1%, mostly due to lower spending on our various programs. R&D expenses in Fiscal 2024 were also reduced by the recognition of Canadian federal non-refundable tax credits ($1,488,000).

R&D expenses in the fourth quarter of Fiscal 2024 were negatively impacted by an impairment loss of the intangible asset of $3,488,000 related to the acquisition of our oncology program. The Company recorded no such provision in the three-month period ended November 30, 2024.

R&D expenses in Fiscal 2023 were negatively impacted by a provision of $3,042,000 related to sudocetaxel zendusortide material which could expire before Theratechnologies is able to use it in our clinical program. We recorded no such provision in Fiscal 2024.

Selling Expenses

Selling expenses for Fiscal 2024 were $25,419,000 compared to $26,769,000 for Fiscal 2023. The decrease in selling expenses in Fiscal 2024 is due in large part to tighter expense control in commercialization activities. Spending in the third quarter and fourth quarters of Fiscal 2024 has stabilized following the completion of cost-cutting measures implemented in Fiscal 2023.

The amortization of the intangible asset value for the EGRIFTA SV and Trogarzo commercialization rights is also included in selling expenses. As such, the Company recorded amortization expense of $1,440,000 for Fiscal 2024 compared to $2,513,000 in Fiscal 2023.

General and Administrative Expenses

General and administrative expenses for Fiscal 2024 were $14,852,000 compared to $15,617,000 for Fiscal 2023. The decrease in general and administrative expenses is largely due to the implementation of cost-cutting measures announced in Fiscal 2023. General and administrative spending should stabilize in the future as the cost-cutting measures implemented by the Company have been completed.

Net Finance Costs

Net finance costs for Fiscal 2024 were $14,475,000 compared to $12,909,000 in Fiscal 2023. The increase in net finance costs in Fiscal 2024 versus Fiscal 2023 was mostly due to the higher interest expense on the Company’s long-term debt ($687,000), as well as higher loss on long-term debt modifications and repayment related to the amendments to and repayment of the Marathon Credit Agreement ($2,358,000). These higher costs were offset by lower accretion and amortization of deferred financing costs ($1,599,000).

Adjusted EBITDA

Adjusted EBITDA was $20,207,000 for Fiscal 2024 compared to $(2,914,000) for Fiscal 2023. See "Non-IFRS and Non-US-GAAP Measure" below and see "Reconciliation of Adjusted EBITDA" below for a reconciliation to Net Loss for the relevant periods.

Income Tax Expense

Income tax expense for Fiscal 2024 amounted to $2,005,000, versus $421,000 in the same period last year. The increase in Fiscal 2024 is attributable to the higher net fiscal income generated by our operations. The Company recorded Canadian federal non-refundable tax credits ($1,488,000) against research and development expenses, which largely offsets the Canadian federal income tax payable. Refer to Note 20 of the Audited Financial Statements.

Net Loss

Taking into account the revenue and expense variations described above, we recorded a net loss of $8,306,000, or $0.17 per share, in Fiscal 2024 compared to $23,957,000, or $0.91 per share, in Fiscal 2023.

Financial Position, Liquidity and Capital Resources

Going Concern Uncertainty

As part of the preparation of the Financial Statements, management is responsible for identifying events or conditions that indicate a material uncertainty exists that casts substantial doubt on the Company’s ability to continue as a going concern. Substantial doubt regarding the Company’s ability to continue as a going concern exists if events or conditions, considered collectively, indicate that the Company may be unable to honor its obligations as they fall due during a period of at least, but not limited to, 12 months from November 30, 2024. If the Company concludes that events or conditions indicate material uncertainty exists on its ability to continue as a going concern, it must assess whether management’s plans developed to mitigate these events or conditions address the material uncertainty.

For the year ended November 30, 2024, the Company incurred a net loss of $8,306,000 (2023-$23,957,000; 2022-$47,237,000) and had positive cash flows from operating activities of $2,379,000 (2023- negative $5,678,000; 2022 negative $14,692,000). As at November 30, 2024, cash amounted to $5,899,000 and bonds and money market funds amounted to $3,937,000 and the accumulated deficit is $416,887,000. The Company’s ability to continue as a going concern requires the Company to continue to achieve positive cash flows through revenues generation and managing expenses, and meet the covenants of the TD Credit Agreement and the IQ Credit Agreement at all times, which require testing on a quarterly basis.

On January 9, 2025, the Company announced a temporary supply disruption for EGRIFTA SV caused by an unexpected voluntary shutdown of the Company’s contract manufacturer’s facility in the third quarter of 2024 following an inspection by the FDA. The manufacturer resumed manufacturing of EGRIFTA SV, in November 2024. In order to resume distribution of EGRIFTA SV, the Company was required to file a PAS with the FDA describing the changes made by its manufacturer. The Company filed the PAS on December 18, 2024. A PAS is usually reviewed by the FDA within four months of receipt.

On February 13, 2025, the FDA, via its Drug Shortage Staff, indicated that it would allow the Company to sell and distribute newly manufactured batches of EGRIFTA SV even though the product was manufactured without an approved PAS, thereby allowing the Company to sell two manufactured batches of EGRIFTA SV, representing up to six months of supply. Distribution of the product resumed on February 13, 2025.

In its communication of February 13, 2025, the FDA indicated that if the Company plans to submit a new or updated proposal to continue mitigating this shortage beyond these two batches, the Company should submit the shortage mitigation proposal to the Drug Shortage Staff so that the FDA can evaluate the proposal. The Company’s contract manufacturer has already manufactured one additional batch of EGRIFTA SV, and two additional batches are planned before the end of the third quarter of 2025.

The Company’s ability to continue generating revenues through the sale of EGRIFTA SV and to be able to meet the Adjusted EBITDA covenants at all times, to be tested on a quarterly basis, contained in the TD Credit Agreement and the IQ Credit Agreement for a period of at least, but not limited to, 12 months from November 30, 2024, involves significant judgement and is dependent on the full resumption of the distribution of EGRIFTA SV, which is dependant on FDA approval.

Should management’s plans not materialize, the Company may be in default under the TD Credit Agreement and the IQ Credit Agreement, be forced to reduce or delay expenditures and capital additions or sell or liquidate its assets. Portions of management’s plans are outside of their control such as the timing of full resumption of product distribution which requires FDA approval. Therefore, there are scenarios wherein events or conditions combine to create material uncertainty and cast substantial doubt about the Company’s ability to continue as a going concern.

The Audited Financial Statements have been prepared assuming the Company will continue as a going concern, which assumes the Company will continue its operations in the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business. The Audited Financial Statements do not include any adjustments to the carrying values and classification of assets and liabilities and reported expenses that might result from the outcome of this uncertainty and that may be necessary if the going concern basis was not appropriate for the Audited Financial Statements. If the Company was unable to continue as a going concern, material impairment of the carrying values of the Company’s assets, including intangible assets, could be required.

Analysis of cash flows

As at November 30, 2024, cash, cash equivalent in escrow, bonds and money market funds amounted to $19,836,000 compared to $40,387,000 at November 30, 2023. Available cash is invested in highly liquid fixed income instruments including governmental, municipal and paragovernmental organizations, high-grade corporate bonds and money market funds. On November 30, 2024, $10,000,000 was held in escrow pending completion of the Ionis Transaction and is therefore presented as cash equivalent in escrow. See "Subsequent Event".

The Company voluntarily changed its accounting policy in Fiscal 2023 to classify interest paid and received as part of its operating activities, which were previously classified as cash flow from financing activities and interest received as cash flows from investing activities.

During Fiscal 2024, cash flows provided by operating activities were $2,379,000, compared to negative $5,678,000 in Fiscal 2023.

In Fiscal 2024, changes in operating assets and liabilities had a negative impact on cash flow from operations of $5,017,000 (2023-positive impact of $8,133,000). These changes included negative impacts from higher trade and other receivables ($2,195,000), lower provisions ($1,760,000), lower accounts payable and accrued liabilities ($1,830,000), and higher prepaid expenses and deposits ($298,000) while lower tax credits and grants receivable ($281,000) and lower inventories ($785,000) had a positive impact on cash flows from operating activities.

During Fiscal 2024, the Company received net proceeds of $44,576,000 from the issuance of long-term debt and used $64,908,000 (including prepayment penalties and fees) to fully reimburse the Marathon Credit Facility.

During Fiscal 2024, investing activities included the payment of the second tranche of the milestone to TaiMed Biologics related to the approval of the IV push method of administration of Trogarzo ($1,500,000), and was offset by net proceeds from the sale of bonds and money market funds ($2,383,000).

Outstanding Securities Data

As at February 25, 2025, the number of issued and outstanding Common Shares amounted to 45,980,019. The following securities were also issued and outstanding: 5,000,000 Marathon Warrants exercisable into 1,250,000 Common Shares, 5,688,186 share options and 3,381,816 Exchangeable Subscription Receipts.

Subsequent Events

Licensing agreement

On December 3, 2024, the Company has entered into an agreement with Ionis Ionis to license two investigational RNA-targeted medicines developed by Ionis. Under the agreement, the Company receives exclusive rights in Canada to commercialize olezarsen, which is being evaluated for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG), and donidalorsen, which is being evaluated for the treatment of hereditary angioedema (HAE).

The Company paid $10,000,000 on December 5, 2024, upon execution of the agreement, which cash equivalent was held in escrow at November 30, 2024 from IQ. The Company also agreed to cash milestone payments based on the achievement of receipt of regulatory approval milestone and receipt of public reimbursement approval milestone (up to $5,750,000), annual sales targets at three different tiers (up to $7,000,000) for donidalorsen only. In addition, Ionis will also be entitled to receive tiered double-digit royalties on annual net sales of each medicine. Royalties on annual net sales of both medicines will be owed for a period of up to 12 years.

The Company will be responsible for filing, obtaining and maintaining regulatory approval for olezarsen and donidalorsen in Canada. Ionis will be manufacturing and supplying both products to Theratechnologies and has granted the Company a right to manufacture both products in certain limited circumstances.

The term of the licensing agreement with Ionis will continue until the Company permanently ceases commercializing all licensed products in Canada, or unless earlier terminated in accordance with customary termination provisions for transactions of this like-nature.

Tariffs

On February 1, 2025, the President of the United States signed an executive order which provided that, effective February 4, 2025, most goods imported into the United States would be subject to a 25% tariff. The application of the order was subsequently suspended; however there are discussions about the re-introduction of those tariffs on goods exported from Canada to the United States.

EGRIFTA SV is exported to the United States. It is too early to determine whether these tariffs will apply to pharmaceutical products and how they would directly impact the Company. The Company expects that such tariffs, if effective, will likely have an adverse effect on its financial results.

11

Reconciliation of Adjusted EBITDA

(In thousands of U.S. dollars)

Three-month periods
ended November 30
Years ended

November 30

2024    2023    2024    2023    2022   

Net loss

(7,903) (2,755) (8,306) (23,957) (47,237)

Add :

Depreciation and

amortization1

493 576 2,761 3,315 12,471

Net Finance costs2

7,801 5,352 14,475 12,909 6,886

Income taxes

1,021 73 2,005 421 443

Share-based

compensation

2,195 418 3,549 2,215 3,872

Inventory provision3

661 50 1,749 220 1,477

Restructuring costs4

-  1,244 486 1,963 - 

Impairment loss on

intangible assets

3,488 -  3,488 -  - 

Adjusted EBITDA

7,756 4,958 20,207 (2,914) (22,088)

             

1 Includes depreciation of property and equipment, amortization of intangible, other assets and right-of-use assets.

2 Includes all finance income and finance costs consisting of: Foreign exchange, interest income, accretion expense and amortization of deferred financing costs, interest expense, write-offs, gain or loss on financial instruments carried at fair value and loss on debt modification and repayment and gain on lease termination.

3 Inventory provision pending marketing approval of the F8 Formulation.

4 Restructuring costs include severance and other expenses associated with termination of employment related to the reorganization announced in July 2023 and completed in October 2023, as well as the decision to cease early stage R&D activities in 2024.

12

Conference Call Details

The conference call will be held at 8:30 a.m. (ET) on February 26, 2025, to discuss the results and recent business updates.

The call will be hosted by Paul Lévesque, President and Chief Executive Officer, who will be joined by other members of the management team, including Philippe Dubuc, Senior Vice President and Chief Financial Officer, Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer and John Leasure, Global Commercial Officer. They will be available to answer questions from participants following prepared remarks.

Participants are encouraged to join the call at least ten minutes in advance to secure access. Conference call dial-in and replay information can be found below.

CONFERENCE CALL INFORMATION

Conference Call Date

February 26, 2025

Conference Call Time

8:30 a.m. ET

Webcast link

View Source

Dial in

1-877-513-4119 (toll free) or 1-412-902-6615 (international)

Access Code

4430181
CONFERENCE CALL REPLAY

Toll Free

1-877-344-7529 (US) / 1-855-669-9658 (Canada)

International Toll

1-412-317-0088
Replay Access Code

3856571
Replay End Date

March 5, 2025

To access the replay using an international dial-in number, please select this link:

View Source

An archived webcast will also be available on the Company’s Investor Relations website under ‘Past Events’.

On February 26, 2025 Argobio and the Institut Pasteur reported the launch of Enodia Therapeutics, a groundbreaking French biotech company dedicated to block and degrade disease-causing proteins for treating cancer, inflammatory diseases and viral infections (Press release, Argobio, FEB 26, 2025, View Source [SID1234650658]). "With the convergence of an unprecedented diverse set of small molecules inhibitors of the Sec61/translocon molecular complex and advancements in generative artificial intelligence (AI), our vision is to develop novel small molecules drugs with good pharmaceuticals properties that could overcome the most critical limitations of today’s medicines," said Yves Ribeill, CEO of Enodia Therapeutics.

Schedule your 30 min Free 1stOncology Demo!
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Enodia Therapeutics stems from pioneering research at the Institut Pasteur, with the discovery of the mechanism of action of Mycolactone, a natural Sec61 inhibitor responsible for Buruli Ulcers. "Our infectious diseases research revealed a new way to target disease-causing proteins. This breakthrough highlights how fundamental research can help uncover entirely new therapeutic opportunities," said Pr. Caroline Demangel, co-founder of Enodia Therapeutics and Head of the Immunobiology and Therapy Unit at the Institut Pasteur.

Rooted in groundbreaking research at the Institut Pasteur and supported by Argobio, Enodia Therapeutics received Pfizer x BioLabs’ prestigious Golden Ticket Award. "This recognition supports our newest small molecule Targeted Protein Degrader (TPD) developed by the combined teams of Argobio and the Institut Pasteur. We are grateful for Pfizer’s support and proud to be part of the vibrant BioLabs life sciences ecosystem in Paris Hotel Dieu, where collaboration and innovation are driving significant advancements in healthcare," Yves Ribeill remarked.

"Pfizer is committed to supporting innovative biotech startups that have the potential to redefine patient care. We are excited to see how Enodia Therapeutics will harness its technology for novel treatment approaches," said Dr. Luca Mollo, Vice-President and Medical Director at Pfizer in France.

Enodia Therapeutics was incubated by Argobio, a premier French biotech studio company dedicated to fostering innovative science and accelerating its transition into a fully-fledged biotech company. The scientific project behind Enodia Therapeutics was supported by the Institut Pasteur’s Innovation Accelerator. The aim of this program is to accelerate the market launch of innovative products resulting from laboratory discoveries. With the creation of its first spin-off company in 1997, the Institut Pasteur has been a pioneer in the creation of spin-off companies based on its research. To date the Institut Pasteur has been involved in the development of 38 spin-off companies.

On February 26, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the fourth quarter and full year 2024 and recent business highlights (Press release, Geron, FEB 26, 2025, View Source [SID1234650627]).

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"2024 was a terrific year for Geron and for RYTELO, our first-in-class telomerase inhibitor, which we believe represents a highly differentiated treatment with blockbuster potential in the high unmet need, lower-risk MDS patient population. We also continued to progress our development efforts in relapsed/refractory myelofibrosis, which could potentially double our commercial opportunity if our IMpactMF Phase 3 trial reads out positively and we are approved in this indication. From a financial perspective, we ended the year with a strong cash position, and Q3 and Q4 revenues exceeded our expectations. Heading into 2025, we are excited by the strategic and leadership changes we put in place early in the launch, which we believe will position us to increase our revenue growth trajectory and more fully capture the significant commercial opportunity over the next several quarters," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.

Recent Business Highlights

Continued execution on U.S. commercial launch, with net product revenue for RYTELO (imetelstat) of $47.5 million in the fourth quarter of 2024 and $76.5 million since launch at the end of June 2024, following approval by the U.S. Food and Drug Administration (FDA).
Received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in December 2024 recommending approval of RYTELO for the treatment of certain adult patients with transfusion-dependent anemia due to lower-risk MDS. Subject to receiving regulatory approval, which is expected in the first half of 2025, Geron is preparing to commercialize RYTELO in select EU countries in 2026.
Achieved approximately 80% enrollment in the Phase 3 IMpactMF trial evaluating imetelstat in patients with relapsed/refractory myelofibrosis (R/R MF). Based on our current planning assumptions for enrollment and event (death) rates in the trial, we now expect the interim analysis for overall survival may occur in the second half of 2026 (when approximately 35% of planned enrolled patients have died) and the final analysis may occur in the second half of 2028 (when approximately 50% of planned enrolled patients have died).
Presented new data at the 66thAmerican Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024, including analyses of IMerge Phase 3 data suggesting clinical activity of imetelstat in patients with lower-risk MDS regardless of type or number of prior therapies and Phase 1 findings from IMproveMF suggesting tolerability of imetelstat in combination with ruxolitinib as a potential frontline therapy in patients with MF.
Fourth Quarter 2024 Financial Results

As of December 31, 2024, we had approximately $502.9 million in cash, cash equivalents, restricted cash and marketable securities.

Net Loss

For the three and twelve months ended December 31, 2024, the Company reported a net loss of $25.4 million, or $0.04 per share, and $174.6 million, or $0.27 per share, respectively, compared to $52.0 million, or $0.09 per share, and $184.1 million, or $0.32 per share, respectively, for the three and twelve months ended December 31, 2023.

Revenues

Total product revenue, net for the three and twelve months ended December 31, 2024, was $47.5 million and $76.5 million, respectively. There was no product revenue in the prior year periods, given that RYTELO was approved by the FDA in June 2024.

Total net revenue for the three and twelve months ended December 31, 2024, was $47.5 million and $77.0 million, respectively, compared to $23,000 and $237,000 for the same periods in 2023. Total net revenue includes license fees and royalties in addition to any product revenue, net. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was approved by the FDA in June 2024.

Operating Expenses

Total operating expenses for the three and twelve months ended December 31, 2024, were $67.6 million and $250.7 million, respectively, compared to $54.3 million and $194.2 million for the same periods in 2023.

Cost of goods sold was approximately $783,000 and $1.3 million for the three and twelve months ended December 31, 2024, respectively, which consisted of costs to manufacture and distribute RYTELO, compared to nil in the prior year periods.

Research and development expenses for the three and twelve months ended December 31, 2024, were $23.4 million and $103.7 million, respectively, and $32.9 million and $125.0 million, for the same periods in 2023. The decrease is primarily due to manufacturing and quality costs that were capitalized in the current period due to FDA approval of RYTELO, compared to being expensed in the prior period. The decrease is partially offset by an increase in labor costs due to higher headcount and incentive and stock-based compensation expense recognized due to the vesting of performance-based stock options upon FDA approval of RYTELO.

Selling, general and administrative expenses for the three and twelve months ended December 31, 2024, were $43.4 million, and $145.7 million, respectively, and $21.4 million and $69.1 million for the same periods in 2023. The increase in general and administrative expenses in 2024 as compared to 2023 primarily reflects higher personnel-related expenses related to increased headcount to support commercial launch of RYTELO in the U.S. and stock-based compensation expense recognized upon FDA approval of RYTELO due to the vesting of performance-based stock options.

Interest income was $5.2 million and $19.6 million for the three and twelve months ended December 31, 2024, respectively, compared to $4.6 million and $18.2 million for the same periods in 2023. The increase in interest income in 2024 compared to 2023 primarily reflects a larger marketable securities portfolio due to the receipt of net cash proceeds from the underwritten offering completed in March 2024, as well as higher yields from marketable securities purchases. Interest earned in future periods will depend on the size of our marketable securities portfolio and prevailing interest rates.

Interest expense was $8.7 million and $18.5 million for the three and twelve months ended December 31, 2024, respectively, compared to $2.3 million and $8.3 million or the same periods in 2023. The increase in interest expense primarily reflects $5.3 million in non-cash interest expense related to our agreement with Royalty Pharma and an increased principal debt balance under the Pharmakon loan agreement and the Hercules loan agreement which was repaid in the fourth quarter of 2024. Interest expense reflects interest owed under the loan agreements, interest expense recognized under the Royalty Pharma agreement, as well as amortization of associated debt issuance costs and debt discounts using the effective interest method and accrual for an end of term charge.

Loss on extinguishment of debt

We recorded a loss on the extinguishment of debt of $1.7 million for the twelve months ended December 31, 2024. The loss is related to the settlement of debt outstanding under the terminated Hercules loan agreement.

2025 Financial Guidance

For fiscal year 2025, we expect total operating expenses to be in the range of approximately $270 million to $285 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

We expect to reach profitability without additional financing if our current internal sales and operating expense expectations are met. Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund our projected operating requirements for the foreseeable future.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Wednesday, February 26, 2024, to discuss business updates and fourth quarter and full year 2024 financial results.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source

About RYTELO (imetelstat)

RYTELO (imetelstat) is an FDA-approved oligonucleotide telomerase inhibitor for the treatment of adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

A marketing authorization application for RYTELO is under review by the European Commission as a monotherapy treatment for adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration.

On February 26, 2025 United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported its financial results for the quarter and year ended December 31, 2024 (Press release, United Therapeutics, FEB 26, 2025, View Source [SID1234650643]). Full year 2024 revenues rose to a record $2.88 billion, reflecting 24% growth over 2023.

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"I want to congratulate every Unitherian for their relentless dedication, which has allowed us to deliver a third consecutive year of record revenue," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "On top of that, our three-year cascade of clinical and regulatory events is under way: both TETON studies in idiopathic pulmonary fibrosis are enrolled, facilitating data starting the second half of this year; ralinepag, our potentially best-in-class once-daily oral prostacyclin agonist, will generate data next year; and this month we announced FDA clearance to start the first potentially registration-enabling xenotransplantation study with our UKidney."
Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, "Our commercial foundation continues to operate from a place of strength, propelled by robust fourth quarter performance across our product portfolio, which capped a record-setting year. We look forward to continuing this momentum in 2025 as our sales and marketing teams continue their efforts to ensure that prescribers are educated on the benefits of our broad array of treprostinil products, which are widely regarded as a cornerstone for treating pulmonary hypertension."
Fourth Quarter and Full Year 2024 Financial Results
Key financial highlights include (in millions, except per share data):
Three Months Ended
December 31, Year Ended
December 31,
2024 2023 2024 2023

Total revenues $ 735.9 $ 614.7 $ 2,877.4 $ 2,327.5
Net income $ 301.3 $ 217.1 $ 1,195.1 $ 984.8
Net income, per basic share $ 6.74 $ 4.62 $ 26.44 $ 21.04
Net income, per diluted share $ 6.19 $ 4.36 $ 24.64 $ 19.81

Revenues
The table below presents the components of total revenues (dollars in millions):
Three Months Ended
December 31, Dollar Change Percentage Change Year Ended
December 31, Dollar Change Percentage Change
2024 2023 2024 2023
Net product sales:
Tyvaso DPI(1)
$ 273.2 $ 213.7 $ 59.5 28 % $ 1,033.6 $ 731.1 $ 302.5 41 %
Nebulized Tyvaso(1)
142.7 136.9 5.8 4 % 586.8 502.6 84.2 17 %
Total Tyvaso 415.9 350.6 65.3 19 % 1,620.4 1,233.7 386.7 31 %
Remodulin(2)
134.5 115.1 19.4 17 % 538.1 494.8 43.3 9 %
Orenitram
107.8 84.1 23.7 28 % 434.3 359.4 74.9 21 %
Unituxin
67.5 54.2 13.3 25 % 238.7 198.9 39.8 20 %
Adcirca
4.7 6.8 (2.1) (31) % 23.8 28.9 (5.1) (18) %
Other 5.5 3.9 1.6 41 % 22.1 11.8 10.3 87 %
Total revenues $ 735.9 $ 614.7 $ 121.2 20 % $ 2,877.4 $ 2,327.5 $ 549.9 24 %

(1)Net product sales include both the drug product and the respective inhalation device.

(2)Net product sales include sales of infusion devices, including the Remunity Pump.

Fourth Quarter 2024 Compared to Fourth Quarter 2023. Total Tyvaso revenues grew by 19 percent to $415.9 million in the fourth quarter of 2024, compared to $350.6 million in the fourth quarter of 2023. This growth was primarily driven by growth in Tyvaso DPI revenues, which resulted from an increase in quantities sold of $62.7 million and, to a lesser extent, a price increase, partially offset by higher gross-to-net deductions. The increase in Tyvaso DPI quantities sold was due to continued growth in the number of patients following the product’s launch, including growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and, to a lesser extent, increased commercial utilization following implementation of the Part D redesign under the Inflation Reduction Act (IRA). The growth in Remodulin revenues resulted from an increase in U.S. Remodulin revenues and, to a lesser extent, an increase in international Remodulin revenues, driven, in both cases, by an increase in quantities sold. The increase in Orenitram revenues resulted from an increase in quantities sold and, to a lesser extent, a price increase. The increase in Orenitram quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Part D redesign under the IRA. The increase in Unituxin revenues resulted from an increase in quantities sold and a price increase.

Full Year 2024 Compared to Full Year 2023. Total Tyvaso revenues grew by 31 percent to $1,620.4 million in 2024, compared to $1,233.7 million in 2023. The growth in Tyvaso DPI revenues resulted from an increase in quantities sold of $269.2 million and, to a lesser extent, price increases, partially offset by higher gross-to-net revenue deductions. The increase in Tyvaso DPI quantities sold was primarily due to continued growth in the number of patients following the product’s launch (including by PH-ILD patients) and, to a lesser extent, increased commercial utilization following implementation of the Part D redesign under the IRA. The growth in nebulized Tyvaso revenues resulted primarily from an increase in quantities sold of $51.9 million and, to a lesser extent, a price increase. Growth in nebulized Tyvaso was also driven by continued growth in use by PH-ILD patients. The growth in Remodulin revenues resulted from an increase in U.S. Remodulin revenues, driven by an increase in quantities sold. The growth in Orenitram revenues resulted from an increase in quantities sold and, to a lesser extent, a price increase. The increase in Orenitram quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Part D redesign under the IRA. The growth in Unituxin revenues resulted from a price increase and an increase in quantities sold.
2

The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions):
Three Months Ended December 31,
Year Ended December 31,
2024 2023 2024 2023
U.S.
ROW
Total
U.S. ROW
Total
U.S.
ROW
Total
U.S.
ROW
Total
Net product sales:
Tyvaso DPI(1)
$ 272.8 $ 0.4 $ 273.2 $ 213.7 $ — $ 213.7 $ 1,033.2 $ 0.4 $ 1,033.6 $ 731.1 $ — $ 731.1
Nebulized Tyvaso(1)
136.4 6.3 142.7 123.7 13.2 136.9 545.5 41.3 586.8 477.1 25.5 502.6
Total Tyvaso 409.2 6.7 415.9 337.4 13.2 350.6 1,578.7 41.7 1,620.4 1,208.2 25.5 1,233.7
Remodulin(2)
118.0 16.5 134.5 106.3 8.8 115.1 464.2 73.9 538.1 414.6 80.2 494.8
Orenitram 107.8 — 107.8 84.1 — 84.1 434.3 — 434.3 359.4 — 359.4
Unituxin 61.8 5.7 67.5 48.7 5.5 54.2 219.6 19.1 238.7 181.3 17.6 198.9
Adcirca 4.7 — 4.7 6.8 — 6.8 23.8 — 23.8 28.9 — 28.9
Other 4.2 1.3 5.5 2.6 1.3 3.9 19.1 3.0 22.1 9.8 2.0 11.8
Total revenues $ 705.7 $ 30.2 $ 735.9 $ 585.9 $ 28.8 $ 614.7 $ 2,739.7 $ 137.7 $ 2,877.4 $ 2,202.2 $ 125.3 $ 2,327.5

(1) Net product sales include both the drug product and the respective inhalation device.
(2) Net product sales include sales of infusion devices, including the Remunity Pump.
Expenses
Cost of sales. The table below summarizes cost of sales by major category (dollars in millions):
Three Months Ended
December 31, Dollar Change Percentage Change Year Ended
December 31, Dollar Change Percentage Change
2024 2023 2024 2023
Category:
Cost of sales $ 74.8 $ 70.1 $ 4.7 7 % $ 304.3 $ 255.1 $ 49.2 19 %
Share-based compensation expense(1)
1.1 0.9 0.2 22 % 5.4 2.4 3.0 125 %
Total cost of sales $ 75.9 $ 71.0 $ 4.9 7 % $ 309.7 $ 257.5 $ 52.2 20 %

(1)See Share-based compensation below.
Cost of sales, excluding share-based compensation. The increase in cost of sales for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to an increase in Tyvaso DPI royalty expense and product costs driven by growth in Tyvaso DPI revenues.
3

Research and development expense. The table below summarizes the nature of research and development expense by major expense category (dollars in millions):
Three Months Ended
December 31, Dollar Change Percentage Change Year Ended
December 31, Dollar Change Percentage Change
2024 2023 2024 2023
Category:
External research and development(1)
$ 63.7 $ 50.4 $ 13.3 26 % $ 217.5 $ 192.0 $ 25.5 13 %
Internal research and development(2)
50.3 43.2 7.1 16 % 183.6 146.6 37.0 25 %
Share-based compensation expense(3)
6.7 5.7 1.0 18 % 29.1 15.6 13.5 87 %
Other(4)
13.1 52.1 (39.0) (75) % 50.8 53.8 (3.0) (6) %
Total research and development expense $ 133.8 $ 151.4 $ (17.6) (12) % $ 481.0 $ 408.0 $ 73.0 18 %

(1)External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product.

(2)Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities.
(3)See Share-based compensation below.

(4)Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products, adjustments to the fair value of our contingent consideration obligations, and costs to acquire certain in-process research and development (IPR&D) assets. During the year ended December 31, 2024, we recorded $40.2 million and $8.0 million in expense related to upfront non-refundable licensing payments for drug delivery device technologies and ex vivo lung perfusion technology, respectively. During the quarter and year ended December 31, 2023, we recorded $46.0 million in IPR&D expense in connection with the acquisition of IVIVA Medical, Inc. (IVIVA).

Research and development, excluding share-based compensation. The decrease in research and development expense for the quarter ended December 31, 2024, as compared to the same period in 2023, was primarily due to IPR&D expense we recorded in connection with the acquisition of IVIVA during the quarter ended December 31, 2023; partially offset by increased expenditures related to manufactured organ and organ alternative projects and upfront non-refundable licensing payments related to ex vivo lung perfusion technology.

The increase in research and development expense for the year ended December 31, 2024, as compared to the same period in 2023, was due to: (1) increased expenditures related to manufactured organ and organ alternative projects; (2) non-refundable licensing payments for drug delivery device technologies and ex vivo lung perfusion technology; and (3) increased expenditures related to the TETON studies of nebulized Tyvaso in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These increases were partially offset by the impact of an IPR&D expense recorded during the year ended December 31, 2023 in connection with the acquisition of IVIVA, which expense did not recur in 2024.
4

Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):
Three Months Ended
December 31, Dollar Change Percentage Change Year Ended
December 31, Dollar Change Percentage Change
2024 2023 2024 2023
Category:
General and administrative(1)
$ 116.3 $ 98.1 $ 18.2 19 % $ 432.8 $ 374.2 $ 58.6 16 %
Litigation accrual
6.0 — 6.0
NM(3)
71.1 — 71.1
NM(3)
Sales and marketing 27.0 24.1 2.9 12 % 96.3 81.8 14.5 18 %
Share-based compensation expense(2)
19.2 10.0 9.2 92 % 109.5 21.1 88.4 419 %
Total selling, general, and administrative expense $ 168.5 $ 132.2 $ 36.3 27 % $ 709.7 $ 477.1 $ 232.6 49 %

(1)Excluding litigation accrual. See Litigation accrual section below.
(2)See Share-based compensation below.
(3)Calculation is not meaningful.
General and administrative, excluding litigation accrual and share-based compensation. The increase in general and administrative expense for the quarter and year ended December 31, 2024, as compared to the same periods in 2023, was primarily due to increases in: (1) personnel expense due to growth in headcount; (2) legal expenses related to litigation matters; and (3) consulting expenses.

Litigation accrual. As of December 31, 2024, we accrued a liability of $71.1 million related to ongoing litigation with Sandoz Inc., reflecting the final judgment and post-judgment interest accrued through the end of 2024. We currently do not expect that the amount of any loss in excess of this accrual would be material to our financial results; however, the amount ultimately payable, if any, could be higher or lower than this amount depending on the amount of post judgment interest and the outcome of appeals, as discussed in Note 14—Litigation, to our consolidated financial statements included within our Annual Report on Form 10-K for the year ended December 31, 2024. The litigation accrual is included within selling, general, and administrative in our consolidated statements of operations.

Sales and marketing, excluding share-based compensation. The increase in sales and marketing expense for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to increases in: (1) personnel expense due to growth in headcount; (2) marketing expenses; and (3) consulting expenses.
5

Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions):
Three Months Ended
December 31, Dollar Change Percentage Change Year Ended
December 31, Dollar Change Percentage Change
2024 2023 2024 2023
Category:
Stock options $ 8.0 $ 2.9 $ 5.1 176 % $ 29.8 $ 15.4 $ 14.4 94 %
Restricted stock units 17.8 14.1 3.7 26 % 79.7 52.4 27.3 52 %
Share tracking awards plan (STAP)
0.6 (0.9) 1.5 167 % 32.3 (30.7) 63.0 205 %
Employee stock purchase plan 0.6 0.5 0.1 20 % 2.2 2.0 0.2 10 %
Total share-based compensation expense $ 27.0 $ 16.6 $ 10.4 63 % $ 144.0 $ 39.1 $ 104.9 268 %

The increase in share-based compensation expense for the quarter ended December 31, 2024, as compared to the same period in 2023, was primarily due to: (1) an increase in stock option expense due to a greater number of awards granted in 2024, as compared to the same period in 2023; (2) an increase in restricted stock unit expense due to a greater number of awards remaining outstanding in 2024, as compared to the same period in 2023; and (3) an increase in STAP expense driven by a two percent decrease in our stock price during the quarter ended December 31, 2024, as compared to a three percent decrease in our stock price for the same period in 2023. The increase in share-based compensation expense for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to: (1) an increase in STAP expense driven by a 60 percent increase in our stock price during 2024, as compared to a 21 percent decrease in our stock price during 2023; (2) an increase in restricted stock unit expense due to a greater number of awards granted and remaining outstanding in 2024, as compared to the same period in 2023; and (3) an increase in stock option expense due to a greater number of awards granted in 2024, as compared to the same period in 2023.

Other (expense) income, net. The change in other (expense) income, net for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to net unrealized gains on equity securities.
Income tax expense. Income tax expense was $343.9 million for the year ended December 31, 2024, compared to $289.5 million for the same period in 2023. For the years ended December 31, 2024 and 2023, our effective income tax rates (ETR) were approximately 22 percent and 23 percent, respectively. Our ETR for the year ended December 31, 2024 decreased, compared to our ETR for the year ended December 31, 2023, primarily due to a decrease in nondeductible acquisition costs and an increase in excess tax benefits from share-based compensation, partially offset by an increase in nondeductible compensation.

Share repurchase. In March 2024, we entered into an accelerated share repurchase agreement (the ASR agreement) with Citibank, N.A. (Citi). Under the ASR agreement, we made an aggregate upfront payment of $1.0 billion to Citi and received an aggregate initial delivery of 3,275,199 shares of our common stock on March 27, 2024, which represented approximately 80 percent of the total shares that would be repurchased under the ASR agreement, measured based on the closing price of our common stock on March 25, 2024.

The share repurchase under the ASR agreement was divided into two tranches, resulting in upfront payments of $300 million and $700 million, respectively. The final settlement of the $300 million tranche occurred in June 2024, and we received an additional 181,772 shares of our common stock upon settlement. The final settlement of the $700 million tranche occurred in September 2024, and we received an additional 90,403 shares of our common stock upon settlement. In total, we repurchased 3,547,374 shares of our common stock under the ASR agreement that we currently hold as treasury stock in our consolidated balance sheets.

Webcast
We will host a webcast to discuss our fourth quarter and full year 2024 financial results on Wednesday, February 26, 2025, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at View Source A replay of the webcast will also be available at the same location on our website.

On February 26, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the fourth quarter and year ended December 31, 2024, and provided a business update (Press release, Immunocore, FEB 26, 2025, View Source [SID1234650628]).

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The Company has delivered 11 consecutive quarters of KIMMTRAK (tebentafusp) revenue growth with continued penetration in the U.S. and launches in 14 new territories ex-U.S., while executing on the product’s lifecycle management program through two Phase 3 trials (TEBE-AM and ATOM) in additional melanoma indications.

The Company further advanced its clinical pipeline, enrolling patients in its three Phase 3 trials, initiating patient dosing in its Phase 1 trial with IMC-P115C, its half-life extended candidate targeting PRAME, and administering the first dose of the first PIWIL1-targeted immunotherapy for gastrointestinal cancers.

Supported by a strong balance sheet, the Company also continued to innovate for sustainable growth, progressing two autoimmune candidates from its first-in-class, tissue-specific autoimmune platform towards clinical trial applications in 2025 and 2026.

"In 2024, we continued to grow KIMMTRAK sales, execute on our KIMMTRAK lifecycle management program, advance our deep clinical pipeline, and expand into autoimmune diseases, supported by a strong cash position and disciplined spending," said Bahija Jallal, CEO of Immunocore. "As we enter 2025, we continue enrolling patients in our three Phase 3 melanoma trials, pursuing additional opportunities in our PRAME franchise, and developing the next generation of transformative immunomodulating therapies. We have line of sight to a significant amount of data over the next 12-18 months, starting with the HIV data this quarter."

"In 2024 we launched KIMMTRAK in 14 countries and delivered 30% year-on-year net sales growth resulting in 11 successive quarters of continuous growth since launch," said Ralph Torbay, Head of Commercial. "In 2025, we expect incremental growth in metastatic uveal melanoma driven by further expansion into the U.S. community and additional launches. We will also continue to enroll patients in the Phase 3 TEBE-AM trial for advanced cutaneous melanoma, with data expected in 2026, and the Phase 3 ATOM trial for adjuvant uveal melanoma."

Full Year and Fourth Quarter 2024 Highlights (including post-period)

Financial Results

Total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK (tebentafusp) was $84.1 million in the fourth quarter of 2024, of which $63.8 million was generated in the United States, $17.8 million in Europe and $2.5 million in international regions. For the year ended December 31, 2024, the Company generated net sales of KIMMTRAK in the amount of $310.0 million, of which $226.7 million was in the United States, $73.2 million in Europe and $10.1 million in international regions.

Research & development (R&D) expenses for the year 2024 were $222.2 million, compared to $163.5 million for the year 2023. Selling, general and administrative (SG&A) expenses for the year 2024 were $155.8 million, compared to $144.5 million for the year 2023.

Net loss for the fourth quarter of 2024 was $23.8 million compared to a net loss of $19.7 million in the same period in 2023, and full year net loss for 2024 was $51.1 million compared to a full year net loss of $55.3 million in 2023.

The fourth quarter basic and diluted loss per share was $0.47 compared to $0.40 for the fourth quarter of 2023. Basic and diluted loss per share for the year 2024 was $1.02, compared to $1.13 for the year 2023.

Cash, cash equivalents and marketable securities at December 31, 2024, were $820.4 million. In November 2024, the Company repaid in full its existing Pharmakon loan of $50.0 million.

KIMMTRAK

The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in 24 countries to date for HLA-A*02:01+ people with metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas for KIMMTRAK, including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

In 2024, KIMMTRAK was launched in 14 additional countries (including Australia, Spain, Poland, and the United Kingdom, excluding Scotland) for a total of 24 countries launched at the end of 2024.
The Company plans to expand access to KIMMTRAK through market share growth in key areas, early patient identification, and additional launches globally.
Second-line and later cutaneous melanoma

The Company is currently enrolling the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026.
The Phase 3 is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including options such as investigator’s choice of clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy).
There is great unmet need in second and later-line cutaneous melanoma, with no therapy having shown an Overall Survival (OS) improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced CM patients.
Adjuvant uveal (or ocular) melanoma

In December 2024, the first patient was randomized in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM), led by the European Organisation for Research and Treatment of Cancer (EORTC).
The Company estimates that the HLA-A*02:01 high risk adjuvant uveal melanoma patient population could be up to 1,200 patients.
PRAME portfolio

Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Company randomized the first patient in the registrational Phase 3 clinical trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 patients with first-line, advanced or metastatic cutaneous melanoma.
Selection of the go-forward dose by the independent data monitoring committee is expected in the second half of 2025.
Despite approved therapies, there remains a need for improved progression free survival and overall survival, and there is the potential to address an estimated 10,000 patients.
Phase 1/2 clinical trial of brenetafusp in multiple solid tumors

In 2024, the Company presented clinical data for the ongoing Phase 1/2 trial evaluating brenetafusp, as a monotherapy and in combination with standard of care. Brenetafusp monotherapy showed clinical activity (disease control rate, partial responses, and stable disease) and ctDNA molecular responses in late-line cutaneous melanoma (at ASCO (Free ASCO Whitepaper) 2024) and platinum-resistant, high grade serous ovarian cancer (at ESMO (Free ESMO Whitepaper) 2024).
Brenetafusp was safely combined with anti-PD1 and all tested chemotherapies in the trial.
The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.
The Company estimates that, across all solid tumors, the annual number of patients worldwide who test positive for HLA-A*02:01 and can potentially benefit from this program is up to 150,000.
IMC-P115C (PRAME HLA-A02 Half-Life Extended) & IMC-T119C (PRAME HLA-A24)

In December 2024, the first dose was administered to a patient in the Phase 1 dose escalation trial, in multiple solid tumors, with IMC-P115C.
IMC-P115C is the Company’s first half-life extended ImmTAC therapy – targeting the same PRAME peptide and with the same CD3 effector and TCR specificity as brenetafusp. It is designed to improve patient convenience by reducing the frequency of treatment administration.
The Company submitted a clinical trial application (CTA) to regulatory authorities for IMC-T119C (targeting PRAME HLA-A24), in December 2024.
IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

In December 2024, the first patient was dosed with IMC-R117C (targeting PIWIL1) in the Phase 1/2 dose escalation trial. PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors, including colorectal cancer.
The trial evaluates IMC-R117C in HLA-A*02:01-positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.
Enrolling ImmTAV candidates for a functional cure in infectious diseases

The Company’s bispecific TCR technology platform has potential to offer a new approach for the treatment of chronic infections and aims to eliminate evidence of remaining virus in circulation after a person stops taking medication – known as a ‘functional cure’. Two investigational candidates are in Phase 1 clinical trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

Phase 1 trial of IMC-M113V (Gag-A02) for people living with HIV

The Company continues to enroll people living with HIV (PLWH) in the multiple ascending dose (MAD) part of the Phase 1 clinical trial with IMC-M113V and will present data from the initial three cohorts during the first quarter of 2025.
The trial aims to identify a safe and tolerable dosing schedule, test whether IMC-M113V could lead to reduction in the viral reservoir and, after stopping all therapies (antiretroviral therapies and IMC-M113V), delay or prevent HIV rebound (known as functional cure). A biologically active dose has been reached, and the Company is enrolling more PLWH to further characterize anti-viral activity and explore higher doses.
Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV

The Company completed the single ascending dose (SAD) portion of the Phase 1 trial with IMC-I109V for people living with hepatitis B virus (HBV) and plans to present this data in the second half of 2025.
Tissue-specific down modulation of the immune system for autoimmune diseases

The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

IMC-S118AI for type 1 diabetes

The Company plans to file a CTA or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.
IMC-S118AI is targeted specifically to the pancreatic beta-cell and intended as a disease-modifying treatment in type 1 diabetes. IMC-S118AI recognizes a peptide from pre-pro-insulin protein that is presented by HLA-A02 on beta cells and has a PD1 agonist effector arm.
IMC-U120AI initially for atopic dermatitis – first universal program

IMC-U120AI (CD1a x PD1) is a CD1a-tethered PD1 agonist ImmTAAI therapy. It is Immunocore’s first non-HLA-restricted program (i.e. universal for all populations).
The Company plans to file a CTA/IND for IMC-U120AI in 2026, initially for a Phase 1 dose escalation trial in atopic dermatitis.
CD1a is an HLA-like protein that is expressed on skin and mucosal antigen presenting cells, such as Langerhans cells. Both CD1a and Langerhans cells play an important role in triggering allergic inflammation in atopic dermatitis and potentially other immune diseases.
IMC-U120AI has a dual mechanism of action in that it will block CD1a (which presents lipids) from activating CD1a-specific T cells and will prevent HLA Class I/II (which presents peptides) from activating T cells via PD1 agonism on the T cell.
Corporate update

In February, Dr. William Pao was appointed as a non-executive member of the Company’s Board of Directors. William is the co-founder and Chief Executive Officer of Revelio Therapeutics, Inc. Prior to Revelio, Dr. Pao held executive leadership positions in early- and late-stage R&D at F. Hoffmann-La Roche AG and Pfizer respectively. He is a member of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s board of directors.

Financial Results

Basic and diluted loss per share was $0.47 and $1.02 for the quarter and year ended December 31, 2024, respectively, as compared to a basic and diluted loss per share of $0.40 and $1.13, respectively, for the same periods in 2023. Net loss for the quarter and year ended December 31, 2024, was $23.8 million and $51.1 million, respectively, as compared to $19.7 million and $55.3 million, respectively, for the same periods in 2023.

For the fourth quarter and year ended December 31, 2024, the Company generated net sales of $84.1 million and $310.0 million, respectively, arising from the sale of KIMMTRAK, of which $63.8 million and $226.7 million, respectively was in the United States, $17.8 million and $73.2 million, respectively, was in Europe, and $2.5 million and $10.1 million, respectively, was in the international regions. The increase in net sales was due primarily to increased volume in the United States and global country expansion, as the Company continues its commercialization efforts.

For the fourth quarter and year ended December 31, 2024, Immunocore’s R&D expenses were $60.9 million and $222.2 million, respectively as compared to $45.6 million and $163.5 million for the quarter and year ended December 31, 2023. These increases were primarily driven by expenses incurred for the Company’s PRAME programs as a result of the initiation of our registrational Phase 3 PRISM-MEL-301 clinical trial, scale-up of manufacturing and an increase in the number of patients in combination expansions in the brenetafusp Phase 1/2 clinical trial. R&D expenses incurred for the tebentafusp programs also increased due to the TEBE-AM and ATOM Phase 3 clinical trials. The Company expects R&D expenses to increase in 2025 as the Company further advances clinical and preclinical pipeline candidates.

For the quarter and year ended December 31, 2024, the Company’s SG&A expenses were $42.3 million and $155.8 million, respectively, compared to $41.4 million and $144.5 million for the quarter and year ended December 31, 2023. These increases were primarily related to increases in the number of employees engaged in business support functions to support our growing pipeline and global commercial expansion, and in investments in patient support initiatives, information technology and facilities costs. The Company expects SG&A expenses to be mostly consistent with Q4 2024 expense levels over the course of 2025.

Cash, cash equivalents and marketable securities at December 31, 2024, were $820.4 million. In November 2024, the Company repaid in full its existing Pharmakon loan of $50.0 million.

See the Company’s Annual Report on Form 10-K filed today with the SEC for more information.

Audio Webcast

Immunocore will host a conference call today, February 26, 2025, at 8:00 A.M. ET / 1:00 PM GMT, to discuss the fourth quarter and full year 2024 financial results and provide a business update. The call will also be available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 30 days.

Conference Call Details:
Domestic (toll-free): 877-405-1239
International (toll): +1 201-389-0851

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