On February 12, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Ascendis Pharma, FEB 12, 2025, View Source [SID1234650208]).

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"Having achieved pivotal milestones in 2024, Ascendis is positioned to continue strong revenue growth in 2025 and beyond," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "We believe YORVIPATH is well on its way to establishing itself as the new global standard for the treatment of hypoparathyroidism in adults. SKYTROFA has achieved a leading position in value in the U.S. growth hormone market. And for TransCon CNP, we have a clear path to submit our NDA and MAA as a differentiated treatment of achondroplasia in children. Together with a strong cash balance and established partnerships, I am confident in our ability to become a leading global biopharmaceutical company with multiple blockbuster products and a strong engine for future innovation."

Select 2024 Highlights & Anticipated 2025 Milestones

TransCon hGH
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA fourth quarter 2024 revenue excluding a positive impact due to reversal of €4.6 million of sales deductions related to prior years was ~€54 million (fourth quarter reported 2024 SKYTROFA revenue of €58.5 million).
SKYTROFA full year 2024 revenue excluding €4.7 million of sales deductions related to prior years was ~€202 million (full year reported 2024 SKYTROFA revenue of €197.0 million).
Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025, for FDA review of supplemental BLA for the treatment of adults with growth hormone deficiency; pending approval, U.S. commercial launch planned in the fourth quarter of 2025.
During the third quarter of 2025, plan to submit an Investigational New Drug (IND) application or similar for a basket trial evaluating TransCon hGH in additional indications.
TransCon PTH
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH revenue for the fourth quarter of 2024 totaled €13.6 million and €28.7 million for the full year 2024, as previously announced.
Strong start to U.S. YORVIPATH launch, with 908 prescriptions as of Feb. 7, 2025, and 539 unique prescribing health care providers.
Expect commercial launch in at least five additional Europe Direct countries in 2025.
Eight International Markets exclusive distribution agreements signed covering 50+ countries.
TransCon CNP
(navepegritide)
Following pre-NDA meeting with FDA, on track to submit New Drug Application (NDA) for the treatment of achondroplasia in children during the first quarter of 2025, and to submit Marketing Authorisation Application (MAA) to the European Medicines Agency during the third quarter of 2025.
Presented new data demonstrating additional benefits beyond linear growth, with significant improvements in leg bowing (a common complication in achondroplasia) observed with TransCon CNP compared to worsening observed with placebo in pivotal ApproaCH Trial.
During the fourth quarter of 2025, plan to submit an IND or similar for the treatment of hypochondroplasia.
TransCon hGH / TransCon CNP Combination Treatment
Topline Week 26 results from Phase 2 COACH Trial (TransCon CNP in combination with TransCon hGH) in children with achondroplasia expected in the second quarter of 2025.
Oncology Program
Clinical development of TransCon IL-2 β/γ continues, including ongoing investigation of clinical activity in platinum-resistant ovarian cancer (PROC).
Financial Update
December 31, 2024, cash and cash equivalents totaling €559.5 million.
Subsequent to the year end, in January 2025, received $100 million related to the Exclusive License Agreement with Novo Nordisk announced last year. Including the $100 million upfront payment, cash at the end of 2024 would have totaled €655 million.
Fourth Quarter and Full Year 2024 Financial Results
Total revenue for the fourth quarter of 2024 was €173.9 million, compared to €137.7 million during the same period for 2023. The increase was primarily attributable to the upfront fee of $100 million from Novo Nordisk and the EU launch of YORVIPATH.

Total revenue for 2024 was €363.6 million compared to €266.7 million in 2023. The increase was primarily attributable to the upfront fee of $100 million from Novo Nordisk and greater commercial product revenue. Non-product revenue was €137.9 million in 2024, compared to €88.1 million in 2023.

Total Revenue
(In EUR’000s)

Three Months Ended
December 31, Twelve Months Ended
December 31,
2024
2023
2024
2023
Revenue from external customers
Commercial products 72,130 64,249 225,728 178,663
Licenses 95,853 64,304 122,343 66,077
Other 5,933 9,150 15,570 21,978
Total revenue from external customers 173,916 137,703 363,641 266,718

Commercial Product Revenue
(In EUR’000s)

Three Months Ended
December 31, Twelve Months Ended
December 31,
2024
2023
2024
2023
Revenue from commercial products
SKYTROFA 58,546 64,249 197,001 178,663
YORVIPATH 13,584 — 28,727 —
Total revenue from commercial products 72,130 64,249 225,728 178,663

Research and development (R&D) costs for the fourth quarter of 2024 were €79.3 million, compared to €90.9 million during the same period in 2023. The decline was largely due to lower external development costs for TransCon hGH and TransCon PTH, as well as the Eyconis spin-off. R&D costs for 2024 were €307.0 million compared to €413.5 million in 2023. The lower R&D costs in 2024 was driven primarily by a decrease in external program development costs as well as the Eyconis spin-off.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2024 were €80.2 million, compared to €64.0 million during the same period in 2023. The increase was due to higher employee costs, including the impact from global commercial expansion, and higher external commercial costs. SG&A expenses for 2024 were €291.1 million compared to €264.4 million in 2023. Higher SG&A expenses were primarily due to higher employee related expenses and other general and administrative expenses attributable to organizational growth in support of launch of YORVIPATH in Europe and the U.S.

Total operating expenses for the fourth quarter of 2024 were €159.5 million compared to €154.9 million during the same period in 2023. Total operating expenses for 2024 were €598.1 million compared to €677.9 million in 2023.

Net finance expenses were €33.2 million in the fourth quarter compared to €41.6 million in the same period in 2023. Net finance expenses for 2024 were €74.4 million compared to €0.2 million in 2023. The full year net finance expense increase was driven primarily by non-cash items.

For the fourth quarter of 2024, Ascendis Pharma reported a net loss of €38.5 million, or €0.64 per share (basic and diluted) compared to a net loss of €86.9 million, or €1.54 per share (basic and diluted) for the same period in 2023. For the full year 2024, Ascendis Pharma reported a net loss of €378.1 million, or €6.53 per share (basic and diluted) compared to a net loss of €481.4 million, or €8.55 per share (basic and diluted) in 2023.

As of December 31, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €559.5 million compared to €399.4 million as of December 31, 2023. Subsequent to the year end, we received the $100 million upfront payment from Novo Nordisk which was received in January 2025. As of December 31, 2024, Ascendis Pharma had 60,689,487 ordinary shares outstanding, including 845,887 ordinary shares represented by ADSs held by the company.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its fourth quarter and full year 2024 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days.

On February 12, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company, reported promising early safety and response results from newly diagnosed acute myeloid leukemia (AML) patients dosed in Aptose’s Phase 1/2 TUSCANY trial with a 40 mg dose of tuspetinib in combination with standard of care dosing of venetoclax and azacitidine (TUS+VEN+AZA triplet) (Press release, Aptose Biosciences, FEB 12, 2025, View Source [SID1234650207]). The TUS+VEN+AZA triplet is being developed as a frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy.

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In January 2025, Aptose announced the initiation of the TUSCANY trial and dosing in the first cohort of newly-diagnosed AML patients with the lowest starting dose (40 mg) of TUS as part of the TUS+VEN+AZA triplet, and the early data reveal promising clinical safety and antileukemic activity.

To date, four newly diagnosed AML patients have received the lowest dose of TUS (40 mg) as part of the (TUS+VEN+AZA) combination.
Three patients with unmutated (wildtype) FLT3 (FLT3-WT) completed Cycle 1 of treatment with no dose-limiting toxicities (DLTs) and no dose adjustments.
Two FLT3-WT patients achieved complete remissions (CR and CRh) by the end of Cycle 1.
Notably, a patient with biallelic TP53 mutations and a complex karyotype obtained CR.
The third FLT3-WT patient experienced significant reductions in bone marrow leukemic blasts during Cycle 1 and remains on therapy in Cycle 2.
The fourth patient, harboring FLT3-ITD and NPM1 mutations, is currently dosing in Cycle 1 and is not yet eligible for response evaluation
Pharmacokinetic (PK) analyses for TUS show plasma levels unaffected by the addition of AZA, providing predictability and avoiding the need for dose alterations due to PK interactions.
"These are very promising early results from the TUSCANY trial of TUS+VEN+AZA and the first indicators of the safety and efficacy we expected to see in newly diagnosed AML patients," said Rafael Bejar, M.D., Ph.D., Chief Medical Officer of Aptose. "To achieve a complete remission (CR) in Cycle 1 in a subject harboring a TP53 mutation – one of the most adverse forms of AML – is particularly encouraging. With enrollment ongoing in the TUSCANY study, we look forward to reporting additional data as it becomes available."

"TUS+VEN+AZA triplet therapy has the potential to treat large AML patient populations, including those with traditionally difficult-to-treat mutations, and improve patient outcomes right from the outset of treatment," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. The ability to treat such diverse AML populations – including FLT3 wildtype patients – with a favorable safety profile and without having to alter the standard of care dosing, differentiates our drug from many AML drugs in development."

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study
Tuspetinib based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Responses to TUS were also observed in those with prior-VEN and prior-FLT3 inhibitor (FLT3i) therapies, those with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.

The TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS will be administered in 28-day cycles, beginning at 40mg once daily, with dose escalations planned after a safety review of each dose level. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025. Data will be released as it becomes available.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov.

On February 12, 2025 Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2024 and provided financial expectations for 2025 (Press release, Alkermes, FEB 12, 2025, View Source [SID1234650203]).

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"2024 marked the completion of a multi-year effort to transition the business into a highly profitable, pure-play neuroscience company. We enter 2025 with a diversified portfolio of proprietary commercial products generating substantial profitability and an advancing development pipeline that represents a significant value creation opportunity in one of the most exciting potential new therapeutic categories in neuroscience," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, we are well positioned to deliver on our financial goals and advance the development programs for our portfolio of orexin 2 receptor agonists. This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia and advance ALKS 4510 and ALKS 7290 into planned phase 1 studies in disease areas beyond central disorders of hypersomnolence. Each of these initiatives is an important element of our strategy to unlock what we believe is a multi-billion-dollar market opportunity for this category."

"2024 was Alkermes’ strongest year of financial and operational performance to date. Financially, we generated more than $1 billion in revenue from our proprietary commercial product portfolio, delivered EBITDA from continuing operations of approximately $452 million, repurchased $200 million of the company’s ordinary shares, retired approximately $290 million of debt and ended the year debt-free with approximately $825 million of cash and investments on the balance sheet. Operationally, we completed the sale of our manufacturing business in Ireland and made significant progress advancing our neuroscience development pipeline," said Blair Jackson, Chief Operating Officer of Alkermes. "We will continue to manage the business with a sharp focus on efficiency and profitability as we invest in the programs that we believe will drive the company’s next phase of growth."

Key Financial Highlights

Revenues

(In millions)

Three Months Ended
December 31,

Twelve Months Ended
December 31,

2024

2023

2024

2023

Total Revenues

$

430.0

$

377.5

$

1,557.6

$

1,663.4*

Total Proprietary Net Sales

$

307.7

$

242.0

$

1,083.5

$

920.0

VIVITROL

$

134.1

$

102.4

$

457.3

$

400.4

ARISTADAi

$

96.6

$

83.4

$

346.2

$

327.7

LYBALVI

$

77.0

$

56.2

$

280.0

$

191.9

Profitability

(In millions)

Three Months Ended
December 31,

Twelve Months Ended
December 31,

2024

2023

2024

2023*

GAAP Net Income From Continuing Operations

$

145.7

$

160.6

$

372.1

$

519.2

GAAP Net Income (Loss) From Discontinued Operations

$

0.8

$

(47.8)

$

(5.1)

$

(163.4)

GAAP Net Income

$

146.5

$

112.8

$

367.1

$

355.8

Non-GAAP Net Income From Continuing Operations

$

173.4

$

81.8

$

494.4

$

396.5

Non-GAAP Net Income (Loss) From Discontinued Operations

$

0.8

$

(44.4)

$

(5.1)

$

(152.9)

Non-GAAP Net Income

$

174.2

$

37.4

$

489.3

$

243.7

EBITDA From Continuing Operations

$

170.0

$

72.8

$

452.4

$

486.3

EBITDA From Discontinued Operations

$

1.1

$

(40.5)

$

(5.8)

$

(162.5)

EBITDA

$

171.1

$

32.3

$

446.6

$

323.8

*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the twelve months ended December 31, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA products that would ordinarily have been recognized in prior periods.

Revenue Highlights

LYBALVI

Revenues for the fourth quarter were $77.0 million.
Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023.
During the quarter, the company recorded LYBALVI revenue of approximately $4 million related to year-end inventory fluctuations.
ARISTADAi

Revenues for the fourth quarter were $96.6 million.
Fourth quarter revenues grew 16% compared to the fourth quarter of 2023.
During the quarter, the company recorded ARISTADA revenue of approximately $9 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
VIVITROL

Revenues for the fourth quarter were $134.1 million.
Fourth quarter revenues grew 31% compared to the fourth quarter of 2023.
During the quarter, the company recorded VIVITROL revenue of approximately $23 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
Manufacturing & Royalty Revenues

Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the fourth quarter were $36.5 million.
VUMERITY manufacturing and royalty revenues for the fourth quarter were $35.0 million.
FAMPYRA manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward.
RISPERDAL CONSTA manufacturing revenues for the fourth quarter were $14.7 million.
Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

(In millions)

Three Months Ended
December 31,

Twelve Months Ended
December 31,

2024

2023

2024

2023

R&D Expense – Continuing Operations

$

58.2

$

73.9

$

245.3

$

270.8

R&D Expense – Discontinued Operations

$

(1.1)

$

21.5

$

5.8

$

116.2

SG&A Expense – Continuing Operations

$

147.0

$

169.8

$

645.2

$

689.8

SG&A Expense – Discontinued Operations

$

–

$

19.4

$

–

$

48.6

Balance Sheet

At Dec. 31, 2024, the company recorded cash, cash equivalents and total investments of $824.8 million, compared to $813.4 million at Dec. 31, 2023.
In December 2024, the company prepaid and retired in full all of its outstanding long-term debt in the amount of approximately $290 million.
Financial Expectations for 2025

All line items are according to GAAP, except as otherwise noted.

In millions

2025 Expectations

Total Revenues

$1,340 – $1,430

VIVITROL Net Sales

$440 – $460

ARISTADAi Net Sales

$335 – $355

LYBALVI Net Sales

$320 – $340

Cost of Goods Sold

$185 – $205

R&D Expenses

$305 – $335

SG&A Expenses

$655 – $685

GAAP Net Income a

$175 – $205

EBITDA

$215 – $245

Adjusted EBITDA

$310 – $340

Effective Tax Rate

~17%

a Expected 2025 weighted average basic share count of approximately 165.5 million shares outstanding and a weighted average diluted share count of approximately 169.5 million shares outstanding.

Notes and Explanations

1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and twelve months ended Dec. 31, 2023.

Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Wednesday, Feb. 12, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

On February 12, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos", "Company"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported that it has entered into a securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $105 million, before deducting placement agents’ fees and other expenses (Press release, Aligos Therapeutics, FEB 12, 2025, View Source [SID1234650202]).

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The private placement is being led by a life sciences dedicated investment firm with participation from other new and existing institutional investors.

Aligos currently expects to use the net proceeds from the private placement, together with its existing cash, cash equivalents and investments, to fund the continued advancement of ALG-000184 into a Phase 2 clinical study in subjects with chronic hepatitis B virus infection (CHB) and for other general corporate purposes.

Aligos believes its cash, cash equivalents and investments, including the expected net proceeds from the private placement, will provide sufficient funding of planned operations into the second half of 2026.

In the private placement, Aligos is selling 2,103,307 shares of common stock, consisting of 1,427,000 shares of voting common stock and 676,307 shares of non-voting common stock, pre-funded warrants to purchase up to 1,922,511 shares of voting common stock, and accompanying warrants to purchase up to 2,012,909 shares of voting common stock at a combined price per share of common stock and accompanying warrant of $26.0825 and a combined price per pre-funded warrant and accompanying warrant of $26.0824. Each pre-funded warrant will have a nominal exercise price of $0.0001 per share of voting common stock, will be immediately exercisable and will be exercisable until exercised in full. The accompanying warrants will have an exercise price of $26.02 per share of common stock, will be immediately exercisable and will expire on February 13, 2032. The private placement is expected to close on February 13, 2025 subject to the satisfaction of customary closing conditions.

Jefferies and Piper Sandler are acting as placement agents for the private placement. H.C. Wainwright & Co. is acting as financial advisor in connection with the transaction.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Aligos granted registration rights to the purchasers in private placements, and has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement, the shares of common stock issuable upon exercise of the pre-funded warrants issued in the private placement and the shares of common stock issuable upon exercise of the accompanying warrants issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On February 11, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 434,784 shares of its common stock at a purchase price of $2.415 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Lixte Biotechnology, FEB 11, 2025, View Source [SID1234650254]). In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to an aggregate of 434,784 shares of common stock. The warrants will have an exercise price of $2.29 per share and will be exercisable for five years from the date of issuance. The closing of the offering is expected to occur on or about February 12, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $1.05 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (but not the warrants issued in the private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-278874) originally filed with the Securities and Exchange Commission ("SEC") on April 23, 2024 and became effective on May 2, 2024. The registered direct offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.