On February 8, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the year and final quarter of 2023 (Press release, Ipsen, FEB 8, 2024, View Source [SID1234639941]).

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Extract of consolidated results for FY 2023 and FY 20226:

FY 2023 FY 2022 % change
€m €m Actual CER1
Total Sales 3,127.5 3,025.0 3.4% 6.7%
Core Operating Income 1,001.0 1,115.4 -10.3%
Core operating margin 32.0% 36.9% -4.9% pts
Core Consolidated Net Profit 765.5 872.4 -12.3%
Core earnings per share (fully diluted) €9.15 €10.51 -13.0%
IFRS Operating Income 816.0 729.9 11.8%
IFRS operating margin 26.1% 24.1% 2.0% pts
IFRS Consolidated Net Profit 647.2 647.5 –
IFRS earnings per share (fully diluted) €7.73 €7.81 -1.0%
Free Cash Flow 710.9 817.2 -13.0%
Closing net cash 65.1 398.8 -83.7%

"Solid results in the year have provided an excellent platform for Ipsen in 2024, an exciting period in which we anticipate four launches and further opportunities to expand the pipeline", commented David Loew, Chief Executive Officer, Ipsen. "As Ipsen transforms, improving execution is supporting consistent sales growth, while the productive pipeline is yielding further encouraging results for patients.

"Our external-innovation strategy, underpinned by a strong balance sheet, continues to extend the number of potential medicines across our three therapeutic areas. Following the acquisition of Albireo in 2023 and the successful launch of Bylvay, we look forward to more milestones this year and enriching the pipeline over time through additional external-innovation transactions. I am confident that this strategy will deliver more medicines for patients and ensure the sustainable growth of Ipsen."

2023 progress

Ipsen continued to deliver successfully in 2023 on its strategy, Focus. Together. For patients and society. The growth platforms produced a further double-digit performance, with Cabometyx and Dysport up by 22.9%7 and 14.5%7, respectively. There were contributions from the new medicines, Bylvay (odevixibat), Sohonos (palovarotene) and Tazverik (tazemetostat), while Somatuline (lanreotide), continuing its gradual erosion (-10.4%7), represented only 34% of total sales (FY 2022: 40%).

The decline in the core operating margin to 32.0% (FY 2022: 36.9%) reflected enhanced investment from the acquisitions of Albireo and Epizyme, including a higher level of R&D expenses to fund the new pipeline. Ipsen ended the year with net cash of €65.1m, driven by solid free cash-flow generation of €710.9m.

In March 2023, Ipsen enriched its Rare Disease portfolio and pipeline by acquiring Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The primary focus of the transaction was Bylvay, a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor.

Favorable pipeline developments in 2023 included positive results from the Phase III trials of elafibranor in primary biliary cholangitis (PBC) and Cabometyx in prostate cancer, respectively. Regulatory submission acceptances were received for Onivyde in first-line pancreatic ductal adenocarcinoma
(1L PDAC), as well as for elafibranor. Sohonos and Bylvay were also granted approval during the year by the U.S. Food and Drug Administration (FDA) in fibrodysplasia ossificans progressiva (FOP) and Alagille syndrome, respectively.

2024 priorities and financial guidance
Ipsen anticipates four commercial launches in 2024, following regulatory decisions for Onivyde in 1L PDAC in the U.S (H1), elafibranor in second-line PBC in the U.S. (H1) and in the E.U. (H2), as well as odevixibat in Alagille syndrome in the E.U. (H2). Sohonos, in FOP, was recently launched in the U.S.

The Company will continue to drive benefits from its global efficiencies program, leveraging its current platform, which provide significant further investment for launches and the pipeline.

Ipsen has set the following financial guidance for FY 2024, which excludes any impact from potential late-stage external-innovation transactions:

Total-sales growth greater than 6.0%, at constant currency. Based on the average level of exchange rates in January 2024, an adverse impact on total sales of around 1% from currencies is expected
Core operating margin around 30% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities
Guidance on total sales incorporates expectations for Somatuline of further generic lanreotide products in the U.S and E.U.

Capital-markets day and mid-term financial outlook

Ipsen outlined its next phase of growth at its capital-market day, held in December 2023. Several current and potential near-term launches are set to be complemented by many pipeline milestones over the mid-term to build a strengthened and diversified business, including a combination of seven anticipated and current medicines, each with expected peak sales of at least €500m. This will be augmented by an active external-innovation strategy, designed to provide a platform to drive sustainable pipeline growth.

The Company outlined the following mid-term financial outlook8:

Total-sales average growth of at least 7% per year for the period 2023-2027 at constant exchange rates
A core operating margin in 2027 of at least 32% of total sales
Environment, Social and Governance: Generation Ipsen
Ipsen presented an ambitious sustainability roadmap at the aforementioned capital-markets day, based on Generation Ipsen, the strategy focused on four pillars: Environment, Patients, People and Governance. Good progress was made in 2023.

Ipsen is committed to science-based reductions in greenhouse-gas emissions across the entire value chain. The Company achieved a 36% reduction in Scope 1 & 2 emissions in 2023 vs the 2019 baseline. Scope 3 reductions in 2023, against the same baseline year, amounted to 29%. Ipsen has the ambition to be carbon-neutral by the end of 2025 and reach net-zero emissions by 2045.

With a key focus on patients, the Company has made progress to reduce the length of time between clinical-trial readouts and non-FDA/EMA9 regulatory submissions by 25%. In 2023, 53% of the GLT was comprised of women versus 48% in 2022, while 43% of colleagues were engaged in healthcare or environmental projects in 2023.

Finally, ISO37001 certification for anti-corruption management was renewed in the year.

Consolidated financial statements

The Board of Directors approved the consolidated financial statements on 7 February 2024. The consolidated financial statements have been audited and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available in due course on ipsen.com (regulated-information section).

Conference call
A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

On February 8, 2024 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the fourth quarter and fiscal year 2023, which include the consolidated financial results for GRAIL (Press release, Illumina, FEB 8, 2024, View Source [SID1234639940]).

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"I’m pleased that in the fourth quarter, my first full quarter with the company, Illumina delivered results ahead of our expectations, driven by NovaSeq X instrument and consumables sales," said Jacob Thaysen, Chief Executive Officer. "While our customers generally remain constrained in their purchasing, we are well-positioned for growth as market conditions improve. Illumina is focused on three key priorities to accelerate value creation: driving our top line; focusing on operational excellence, including boosting productivity, cost savings, and customer-focused innovation; and working to resolve GRAIL as quickly as possible."

Fourth quarter consolidated results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts Q4 2023 Q4 2022 Q4 2023 Q4 2022
Revenue $ 1,122 $ 1,083 $ 1,122 $ 1,083
Gross margin 60.1 % 62.1 % 64.4 % 66.6 %
Research and development ("R&D") expense $ 341 $ 346 $ 329 $ 339
Selling, general and administrative ("SG&A") expense $ 485 $ 432 $ 342 $ 351
Goodwill and intangible impairment $ 6 $ — $ — $ —
Legal contingency and settlement $ 6 $ 21 $ — $ —
Operating (loss) profit $ (164) $ (127) $ 51 $ 31
Operating margin (14.6) % (11.7) % 4.6 % 2.9 %
Tax provision (benefit) $ 8 $ (28) $ 26 $ 9
Tax rate (4.9) % 16.8 % 55.4 % 29.3 %
Net (loss) income $ (176) $ (140) $ 22 $ 22
Diluted (loss) earnings per share $ (1.11) $ (0.89) $ 0.14 $ 0.14

(a) See the tables included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Capital expenditures for free cash flow purposes were $51 million for Q4 2023. Cash flow provided by operations was $224 million, compared to cash flow provided by operations of $147 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $173 million for the quarter, compared to $59 million in the prior year period. Depreciation and amortization expenses were $109 million for Q4 2023. At the close of the quarter, the company held $1,054 million in cash, cash equivalents and short-term investments.

Fourth quarter segment results
Illumina has two reportable segments, Core Illumina and GRAIL.

Core Illumina
GAAP Non-GAAP (a)
Dollars in millions Q4 2023 Q4 2022 Q4 2023 Q4 2022
Revenue (b)
$ 1,097 $ 1,065 $ 1,097 $ 1,065
Gross margin (c)
63.3 % 65.9 % 64.7 % 67.3 %
R&D expense $ 260 $ 264 $ 248 $ 257
SG&A expense $ 391 $ 347 $ 259 $ 271
Goodwill and intangible impairment $ 6 $ — $ — $ —
Legal contingency and settlement $ 6 $ 21 $ — $ —
Operating profit
$ 33 $ 70 $ 203 $ 190
Operating margin 3.0 % 6.6 % 18.5 % 17.8 %

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
(b) Core Illumina revenue for Q4 2023 was up 3% as compared to Q4 2022 and up 3% on a constant currency basis. Amounts for Q4 2023 and Q4 2022 both included intercompany revenue of $5 million, which is eliminated in consolidation.
(c) The year-over-year decrease in gross margin was primarily driven by the mix of lower margin strategic partnership revenue, lower instrument margins due to the NovaSeq X launch, which is typical with a new platform introduction, and increased field services and installation costs, partially offset by lower freight costs.

GRAIL
GAAP Non-GAAP (a)
In millions Q4 2023 Q4 2022 Q4 2023 Q4 2022
Revenue $ 30 $ 23 $ 30 $ 23
Gross (loss) profit $ (19) $ (26) $ 14 $ 8
R&D expense $ 84 $ 85 $ 84 $ 85
SG&A expense $ 94 $ 86 $ 83 $ 81
Operating loss $ (197) $ (197) $ (152) $ (159)

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Fiscal year 2023 consolidated results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts 2023 2022 2023 2022
Revenue $ 4,504 $ 4,584 $ 4,504 $ 4,584
Gross margin 60.9 % 64.8 % 65.3 % 68.6 %
R&D expense $ 1,354 $ 1,321 $ 1,325 $ 1,313
SG&A expense $ 1,612 $ 1,297 $ 1,367 $ 1,346
Goodwill and intangible impairment (b)
$ 827 $ 3,914 $ — $ —
Legal contingency and settlement $ 20 $ 619 $ — $ —
Operating (loss) profit $ (1,069) $ (4,179) $ 247 $ 487
Operating margin (23.7) % (91.2) % 5.5 % 10.6 %
Tax provision $ 44 $ 68 $ 98 $ 118
Tax rate (3.9) % (1.6) % 41.8 % 26.0 %
Net (loss) income $ (1,161) $ (4,404) $ 137 $ 336
Diluted (loss) earnings per share $ (7.34) $ (28.00) $ 0.86 $ 2.12

(a) See the tables included in "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
(b) The company recognized $712 million in goodwill and $109 million in intangible asset (IPR&D) impairment related to the GRAIL segment in 2023. The goodwill impairment was primarily due to a decrease in the company’s consolidated market capitalization and a higher discount rate selected for the fair value calculation of the GRAIL reporting unit. The IPR&D impairment was primarily due to a decrease in projected cash flows and a higher discount rate selected for the fair value calculation of the GRAIL IPR&D asset. In 2022, the company recognized $3.91 billion in goodwill impairment related to the GRAIL segment.
Capital expenditures for free cash flow purposes were $195 million for fiscal year 2023. Cash flow provided by operations was $478 million, compared to $392 million in the prior year. Free cash flow (cash flow provided by operations less capital expenditures) was $283 million for the year, compared to $106 million in the prior year. Depreciation and amortization expenses were $432 million for fiscal year 2023.

Fiscal year 2023 segment results

Core Illumina
GAAP Non-GAAP (a)
In millions 2023 2022 2023 2022
Revenue (b)
$ 4,438 $ 4,553 $ 4,438 $ 4,553
Gross margin 64.4 % 68.2 % 65.8 % 69.1 %
R&D expense $ 1,030 $ 1,004 $ 1,001 $ 996
SG&A expense $ 1,248 $ 1,003 $ 1,032 $ 1,069
Goodwill and intangible impairment $ 6 $ — $ — $ —
Legal contingency and settlement $ 20 $ 619 $ — $ —
Operating profit $ 552 $ 481 $ 885 $ 1,081
Operating margin 12.4 % 10.6 % 19.9 % 23.8 %

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
(b) Core Illumina revenue for 2023 was down 3% from 2022, and down 1% on a constant currency basis. Amounts for 2023 and 2022 included intercompany revenue of $26 million and $24 million, respectively, which is eliminated in consolidation.

GRAIL
GAAP Non-GAAP (a)
In millions 2023 2022 2023 2022
Revenue $ 93 $ 55 $ 93 $ 55
Gross (loss) profit $ (96) $ (117) $ 38 $ 17
R&D expense $ 338 $ 330 $ 338 $ 330
SG&A expense $ 366 $ 296 $ 337 $ 279
Goodwill and intangible impairment $ 821 $ 3,914 $ — $ —
Operating loss $ (1,621) $ (4,657) $ (638) $ (592)

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Key announcements by Illumina since Illumina’s last earnings release
•Announced the decision to divest GRAIL, executed through a third-party sale or capital markets transaction, with the goal of finalizing terms by the end of the second quarter 2024
•Submitted a confidential, draft registration statement on Form 10 related to the GRAIL divestment to the U.S. Securities and Exchange Commission
•Signed agreement with Janssen Research & Development, LLC (Janssen) to collaborate on the development of Illumina’s novel molecular residual disease (MRD) assay
•Expanded the Alliance for Genomic Discovery, adding Bristol Myers Squibb (BMS), GSK and Novo Nordisk to join founding member organizations AbbVie, Amgen, AstraZeneca, Bayer, and Merck, who together will co-fund the whole-genome sequencing (WGS) of 250,000 data samples and have access to the resulting data for use in drug discovery and therapeutic development
•Launched the Global Health Access Initiative to support access to pathogen sequencing tools for public health in low- and middle-income countries (LMICs)
•Conducted a stewardship-focused non-deal roadshow led by Illumina’s independent board directors; held discussions with shareholders owning more than half of outstanding shares

A full list of recent Illumina announcements can be found in the company’s News Center.

Key announcements by GRAIL since Illumina’s last earnings release
•Highlighted the presentation of analytical and clinical validation data on a novel prognostic test in early-stage lung cancer, generated through collaboration with the Samsung Medical Centre and AstraZeneca, demonstrating sensitive and specific detection of circulating tumor DNA (ctDNA) for Lung Adenocarcinoma (LUAD) at a clinically meaningful threshold for disease prognostication
•Announced that it will initiate Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare study) following the U.S. Food and Drug Administration’s (FDA) approval of GRAIL’s Investigational Device Exemption (IDE) application and the Centers for Medicare and Medicaid Services’ (CMS) approval for Medicare coverage of the study
•Announced BeniComp, a customized health plan provider, and Curative Insurance, a pioneering healthcare services company, will make Galleri available to eligible patients

A full list of recent GRAIL announcements can be found in GRAIL’s Newsroom.

Financial outlook and guidance
For fiscal year 2024, the company expects Core Illumina revenue to be approximately flat compared to fiscal year 2023 and Core Illumina non-GAAP operating margin to be approximately 20%. While Illumina continues to move as quickly as possible to resolve GRAIL, the company is focusing its financial outlook on Core Illumina, as the specific timing and impact of the GRAIL divestment remains uncertain.

The company provides forward-looking guidance on a non-GAAP basis. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the financial impact of items such as acquisition-related expenses, gains and losses from our strategic investments, fair value adjustments related to contingent consideration and contingent value rights, potential future asset impairments, restructuring activities, and the ultimate outcome of pending litigation without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

Conference call information
The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Thursday, February 8, 2024. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website at investor.illumina.com. Alternatively, individuals can access the call by dialing 877.400.0505 or +1.323.701.0225 outside North America, both using conference ID 1615812. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On February 8, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted six employees nonqualified stock options to purchase an aggregate of 147,000 shares of its common stock with an exercise price of $2.26, which is equal to the closing price of Gritstone’s common stock on February 6, 2024, the date of the grant (Press release, Gritstone Bio, FEB 8, 2024, View Source [SID1234639939]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

On February 8, 2024 Foghorn Therapeutics presented its corporate presentation (Presentation, Foghorn Therapeutics, FEB 8, 2024, View Source [SID1234639938]).

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On February 8, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its business update and financial results for the quarter ended December 31, 2023 (Press release, Curis, FEB 8, 2024, View Source [SID1234639937]).

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Operational Highlights

In December at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper), the Company presented data from both the TakeAim Lymphoma and TakeAim Leukemia studies. A summary of key findings of the data that were presented from the on-going studies are as follows:

TakeAim Lymphoma – data for patients with primary CNS lymphoma (PCNSL) who had failed prior BTKi therapy showed 3 of 5 evaluable patients achieved Complete Response (CR).
TakeAim Leukemia – data for patients with relapsed/refractory (R/R) AML with a FLT3 mutation who received < 3 prior lines of treatment showed 2 of 3 patients achieved CR and the 3rd patient achieved Morphological Leukemia Free State (MLFS).
In addition to the presentations at ASH (Free ASH Whitepaper), Curis announced in December that it had entered into an agreement for an Investigator-Initiated Trial to study the combination of emavusertib and pembrolizumab in patients with metastatic melanoma. In this study, Curis will be responsible for the supply of emavusertib and Merck will be responsible for the supply of pembrolizumab and clinical study costs.

"The R/R PCNSL data presented at ASH (Free ASH Whitepaper) highlight the potential of emavusertib in combination with ibrutinib to address a critical unmet need, for a patient population with no approved treatments, and achieve CR in patients who have failed prior BTKi therapy. The R/R AML FLT3 data highlight emavusertib’s potential to provide targeted anti-cancer activity as a monotherapy. We have also begun working with clinical investigators to initiate a Phase 1 clinical study of emavusertib as an add-on agent to the combination of azacitidine and venetoclax in the front-line setting. Finally, the study evaluating emavusertib and pembrolizumab in metastatic melanoma will explore the potential of emavusertib and IRAK4 inhibition in solid tumors," said James Dentzer, President and Chief Executive Officer of Curis. "We are encouraged by the reaction of the clinical community to the data released at ASH (Free ASH Whitepaper) and are working to open additional clinical sites in the US and Europe for both the TakeAim Leukemia and Lymphoma studies."

Upcoming Milestones

TakeAim Leukemia – updated clinical data from the on-going monotherapy study in the first half of 2024.
TakeAim Lymphoma – updated clinical data from the on-going combination study of emavusertib with ibrutinib in the second half of 2024.
Curis expects initial clinical data from the recently initiated triplet combination study of emavusertib with azacitidine and venetoclax to treat AML patients in the second half of 2024.
Fourth Quarter 2023 Financial Results

For the year ended December 31, 2023, Curis reported a net loss of $47.4 million, or $8.96 per share on both a basic and diluted basis, as compared to a net loss of $56.7 million, or $12.14 per share on both a basic and diluted basis in 2022. For the fourth quarter of 2023, Curis reported a net loss of $11.7 million or $2.03 per share on both a basic and diluted basis as compared to a net loss of $11.3 million or $2.35 per share on both a basic and diluted basis for the same period in 2022.

Revenues, net for the year ended December 31, 2023, were $10.0 million as compared to $10.2 million for the same period in 2022. Revenues for both periods comprise primarily royalty revenues related to Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2023 and 2022 were $2.7 million and $2.9 million, respectively.

Cost of royalties, which relate to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, for the year ended December 31, 2023, were $0.2 million compared to $0.3 million for the same period in 2022. Cost of royalties for the fourth quarters of 2023 and 2022 were $0.1 million for both periods.

Research and development expenses were $39.5 million for the year ended December 31, 2023, as compared to $43.3 million for the same period in 2022. The decrease was primarily attributable to lower employee-related costs due to reduced headcount. Research and development expenses were $10.0 million and $8.7 million for the fourth quarters of 2023 and 2022, respectively.

General and administrative expenses were $18.6 million for the year ended December 31, 2023, as compared to $19.6 million for the same period in 2022. The decrease was primarily attributable to lower employee-related costs due to reduced headcount. General and administrative expenses were $4.9 million and $4.3 million for the fourth quarters of 2023 and 2022, respectively.

Other income, net was $0.9 million for the year ended December 31, 2023, as compared to other expense, net of $3.7 million for the same period in 2022. The increase was attributable to an increase in interest income and a decrease in the non-cash expense related to the sale of future royalties. Other income, net was $0.5 million for the fourth quarter of 2023 as compared to other expense, net of $1.1 million for the same period in 2022.

As of December 31, 2023, Curis’s cash, cash equivalents and investments totaled $56.3 million, and the Company had approximately 5.9 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, February 8, 2024, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website in the Investors section.