On August 6, 2024 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today reported financial results for the three and six months ended June 30, 2024, and provided an operating forecast and business update (Press release, Ligand, AUG 6, 2024, View Source [SID1234645424]). Ligand management will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss this announcement and answer questions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We had a strong quarter and are on track to meet the long-term growth objectives we outlined in December," said Todd Davis, CEO of Ligand. "We added four new commercial-stage programs in the first half of this year, including QARZIBA, an orphan oncology product we acquired following the APEIRON Biologics transaction, Merck’s CAPVAXIVE and Verona Pharma’s Ohtuvayre, which received FDA approval in the second quarter, and Pelthos’ ZELSUVMI which was approved by the FDA earlier this year. Also, our partner, Primrose Bio secured additional outside capital which will enable them to continue building their business, fortifying the value of our long-term interest in the company. These developments underscore our commitment to expand our royalty portfolio, which now includes 12 major commercial-stage programs, double the number of programs we had at the beginning of 2023."

Second Quarter 2024 Financial Results
Total revenues and other income for the second quarter of 2024 were $41.5 million, compared with $26.4 million for the same period in 2023 with the increase primarily due to an increase in royalty revenue and milestone payments earned upon the approval of several key programs. Royalties for the second quarter of 2024 were $23.2 million, compared with $20.9 million for the same period in 2023, with the increase primarily attributable to an increase in sales of Travere Therapeutics’ (Nasdaq:TVTX) FILSPARI and Amgen’s (Nasdaq:AMGN) KYPROLIS. Captisol sales were $7.5 million for the second quarter of 2024, compared with $5.2 million for the same period in 2023, with the change due to the timing of customer orders. Contract revenue and other income was $10.9 million for the second quarter of 2024, compared with $0.2 million for the same period in 2023, with the increase driven by the $5.8 million milestone payment earned upon FDA approval of Ohtuvayre, the $2.0 million milestone payment earned upon FDA approval of CAPVAXIVE, and the $2.3 million milestone payment earned upon the conditional marketing approval of FILSPARI by the European Commission.
Cost of Captisol was $2.9 million for the second quarter of 2024, compared with $1.7 million for the same period in 2023, with the increase due to higher Captisol sales. Amortization of intangibles was $8.3 million for the second quarter of 2024, compared with $8.5 million for the same period in 2023. Research and development expense was $5.4 million for the second quarter of 2024, compared with $6.9 million for the same period in 2023, with the decrease primarily attributed to lower employee related expenses and lab supplies resulting from the Pelican spin-off in September 2023. The decrease was partially offset by the additional operating costs associated with incubating the Pelthos business. General and administrative expense was $17.6 million for the second quarter of 2024, compared with $11.3 million for the same period in 2023, with the increase primarily attributed to higher stock-based compensation and operating costs associated with incubating the Pelthos business.
GAAP net loss from continuing operations for the second quarter of 2024 was $51.9 million, or $2.88 per share, compared with GAAP net income from continuing operations of $2.3 million, or $0.13 per diluted share, for the same period in 2023. GAAP net loss from continuing operations for the second quarter of 2024 included a $13.8 million non-cash unrealized loss from short-term investments associated with Viking Therapeutics (Nasdaq: VKTX) stock, a $26.5 million decrease in the carrying value of our investments, primarily in connection with Takeda

Pharmaceutical’s (NYSE:TAK) soticlestat, and a $33.8 million decrease in our investments in Primrose Bio (private). Our equity ownership interest in Primrose Bio has decreased from 49.9% to 34.3% in connection with their recent financing round. The financing round was at a valuation below the value arrived at when we spun out the Pelican business in September 2023, which resulted in a non-cash reduction in the carrying value of our investment. Adjusted net income from continuing operations for the second quarter of 2024 was $25.8 million, or $1.40 per diluted share, compared to $25.1 million, or $1.42 per diluted share, for the same period in 2023. Excluding the impact of gains from sales of Viking Therapeutics stock in the second quarter of 2023, core adjusted net income from continuing operations for the second quarter of 2023 was $11.7 million, or $0.66 per diluted share. We did not sell any shares of Viking Therapeutics stock in the second quarter of 2024. The increase in core adjusted net income is driven primarily by the 58% increase in revenue. See the table below for a reconciliation of net income from continuing operations to adjusted net income from continuing operations.
As of June 30, 2024, Ligand had cash, cash equivalents and short-term investments of $226.9 million which includes $53.0 million in Viking Therapeutics common stock. In May 2024, Ligand entered into a collar option agreement to hedge against Viking Therapeutics stock price fluctuation risk. Ligand recorded a $15.2 million unrealized gain associated with the collar option agreement during the second quarter of 2024 and the value of that derivative asset is classified as other current assets. On July 8, 2024, Ligand entered into an amended credit agreement with Citibank, N.A., which expands the existing $75 million revolving credit facility to $125 million with a maturity date of October 12, 2026.

Year-to-Date Financial Results
Total revenues and other income for the six months ended June 30, 2024 were $72.5 million, compared with $70.3 million for the same period in 2023. Royalties for the six months ended June 30, 2024 were $42.3 million, compared with $38.6 million for the same period in 2023, with the increase primarily attributable to Amgen’s KYPROLIS, Jazz Pharmaceuticals’ RYLAZE, Merck and Co.’s (NYSE: MRK) VAXNEUVANCE and Travere Therapeutics’ FILSPARI, partially offset by a decline in royalties in CASI Pharmaceuticals Inc.’s (Nasdaq: CASI) EVOMELA and Alvogen’s teriparatide. Captisol sales were $16.7 million for the six months ended June 30, 2024, compared with $15.8 million for the same period in 2023, with the change due to the timing of customer orders. Contract revenue and other income was $13.5 million for the six months ended June 30, 2024, compared with $15.9 million for the same period in 2023, with the decrease driven by a $15.3 million milestone payment earned from Travere Therapeutics upon the FDA approval of FILSPARI in the prior year period, partially offset by the above mentioned current year milestone payments earned.
Cost of Captisol was $5.8 million for the six months ended June 30, 2024, compared with $5.4 million for the same period in 2023, with the increase due to higher total Captisol sales. Amortization of intangibles was $16.4 million for the six months ended June 30, 2024, compared with $17.1 million for the same period in 2023. Research and development expense was $11.3 million for the six months ended June 30, 2024, compared with $13.5 million for the same period in 2023, with the decrease primarily attributed to lower employee related expenses and lab supplies resulting from the Pelican spin-off in September 2023. The decrease was partially offset by additional costs associated with incubating the Pelthos business. General and administrative expense was $28.6 million for the six months ended June 30, 2024, compared with $22.1 million for the same period in 2023, with the increase driven by higher stock-based compensation expense and additional costs associated with incubating the Pelthos business.
GAAP net income from continuing operations for the six months ended June 30, 2024 was $34.2 million, or $1.87 per diluted share, compared with GAAP net income from continuing operations of $45.9 million, or $2.57 per diluted share, for the same period in 2023. The decrease in GAAP net income from continuing operations from the prior year period is due primarily to a $26.5 million decrease mainly in the fair value of our investment in Takeda’s soticlestat and a $36.1 million decrease in our investments in Primrose Bio during the six months ended June 30, 2024, partially offset by the realized gains from short-term investments associated with Viking Therapeutics stock of $60.0 million. Adjusted net income from continuing operations for the six months ended June 30, 2024 was $95.5 million, or $5.23 per diluted share, compared to $65.0 million, or $3.69 per diluted share, for the same period in 2023. Excluding the impact of gains from sales of Viking Therapeutics stock, core adjusted net income from continuing operations for the six months ended June 30, 2024 was $47.6 million, or $2.61 per diluted share, compared with $35.1 million, or $1.99 per diluted share, for the same period in 2023. The increase in core adjusted net income is primarily driven by the increase in adjusted operating income. See the table below for a reconciliation of net income from continuing operations to adjusted net income from continuing operations.

2024 Financial Guidance
Ligand is reaffirming its 2024 financial guidance given on July 8, 2024. The Company expects 2024 royalties to range from $100 million to $105 million, sales of Captisol to range from $25 million to $27 million, and contract revenue to range from $15 million to $25 million. These revenue components result in total revenue forecast of $140 million to $157 million. Core adjusted earnings per diluted share are expected to range from approximately $5.00 to $5.50. This guidance excludes the $60 million realized gain from short-term investments on the sale of Viking Therapeutics stock.

Adjusted Financial Measures
Ligand reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, amortization of financial royalty assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, Pelthos operating loss, impairment of financial royalty assets, loss from equity method investment in Primrose Bio, income tax effect of adjusted reconciling items and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, the Company does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including non-cash adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Second Quarter 2024 and Recent Updates
Business Highlights
On July 8, Ligand announced the $100 million acquisition of APEIRON Biologics, a private biotech company based in Vienna, Austria. Apeiron holds the royalty rights to QARZIBA (dinutuximab beta) for the treatment of high-risk neuroblastoma. QARZIBA was approved by the European Medicines Agency in 2017 and is commercially available today in more than 35 countries. QARZIBA is marketed outside of mainland China by the global pharmaceutical company Recordati S.p.A., which acquired EUSA Pharma (UK) Limited in 2022.
On July 8, Ligand also amended its revolving credit facility with Citibank. The Credit Agreement was amended to, among other things, increase the aggregate revolving credit facility amount from $75 million to $125 million.
On July 24, Palvella Therapeutics, Inc. (private) announced a merger agreement with Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS) in which Palvella anticipates becoming a publicly traded rare disease company upon the close of the merger. In connection with the proposed merger, Palvella secured commitments from a syndicate of leading specialist biotech investors in an oversubscribed $78.9 million concurrent private financing.
The transaction will help advance several clinical milestones for Palvella:
•A Phase 3 pivotal study of QTORIN 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations, a serious, rare genetic and lifelong disease for which there are no FDA-approved therapies. The disease impacts more than 30,000 diagnosed patients in the U.S. QTORIN rapamycin has been granted FDA’s Breakthrough Therapy, Fast Track, and Orphan Designations for the treatment of microcystic lymphatic malformations.
•A Phase 2 study of QTORIN rapamycin for the treatment of cutaneous venous malformations. Cutaneous venous malformations are a serious, rare genetic disease which can cause functional impairment, significantly impact quality of life, and are associated with severe long-term complications. QTORIN rapamycin has been granted FDA’s Fast Track Designation for the treatment of venous malformations.

Notably, if approved, QTORIN rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic lymphatic malformations and cutaneous venous malformations.
As background, Palvella was originally sourced through Ligand’s proactive deal origination efforts. Since Ligand’s first transaction with Palvella, the company has secured significant subsequent equity funding from leading biotech investors, including BVF Partners, Petrichor, Samsara BioCapital, and others. Ligand is entitled to a royalty of 8-9.8% on worldwide commercial sales of QTORIN rapamycin. In addition to Ligand’s royalty, Ligand anticipates owning approximately 2% of the combined company following the close of the reverse merger and concurrent financing.
Portfolio Updates
On July 18, Agenus Inc. (Nasdaq: AGEN), announced the results of its end-of-Phase 2 meeting with the FDA, for the advancement of its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM). Agenus received clarity from the FDA on their Phase III dosing regimen, which is an important achievement. The company also announced topline interim data from its Phase 2 trial, which are showing trends consistent with the Phase 1 study, including an ORR of 19.4% and 6-month survival rate of 90% for the BOT 75mg/BAL combination. The safety profile was manageable and no new signals were observed. Agenus plans to continue future discussions with the FDA as the Phase 2 data mature and will present these data in totality at an upcoming medical conference.

On June 26, Verona Pharma plc (Nasdaq: VRNA) announced FDA approval of Ohtuvayre (ensifentrine), the first inhaled product with a novel mechanism of action available for the maintenance treatment of chronic obstructive pulmonary disease in adult patients in more than 20 years. Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 phosphodiesterase 4 ("PDE3 and PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ligand earned a $5.8 million milestone payment upon FDA approval of Ohtuvayre and will earn an additional $13.8 million upon its commercial launch which is expected to occur during the third quarter of 2024. Ligand is entitled to a royalty of approximately 3% on future worldwide net sales of Ohtuvayre.

On June 17, Merck announced approval from the FDA for CAPVAXIVE, previously known as V116, a 21 valent pneumococcal vaccine for the prevention of Streptococcus pneumoniae infection. Risk of infection is higher among patients that are immunocompromised, suffering chronic health conditions, and adults aged 50 years or older. As the first pneumococcal conjugate vaccine specifically designed for adults, it covers 21 serotypes that account for approximately 85% of cases of invasive pneumococcal disease among individuals 65 and over, including 8 serotypes not covered by any licensed vaccines. Specific serotypes pose potentially greater risk for invasive pneumococcal disease, including pneumococcal bacteremia and meningitis. Following the FDA approval, Merck announced on June 27, that the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously voted to recommend CAPVAXIVE as an option for all adults age 65 and older, for adults 19 to 64 with certain risk factors, and for those over 65 previously vaccinated with other pneumococcal vaccines. The FDA approval of CAPVAXIVE triggered a $2 million milestone payment to Ligand, and Ligand is entitled to a royalty on future worldwide net sales.

On June 17, Ovid Therapeutics (Nasdaq: OVID) announced Takeda’s SKYLINE study of soticlestat in Dravet syndrome narrowly missed its primary endpoint of reduction in convulsive seizure frequency and showed clinically meaningful and nominal significant effects in multiple key secondary efficacy endpoints. Additionally, Takeda’s SKYWAY study in Lennox-Gastaut syndrome missed its primary endpoint of reduction in major motor drop seizures. Soticlestat had a consistent and favorable safety and tolerability profile in both studies. Takeda indicated that it plans to discuss the totality of the data with regulatory authorities.

On June 17, Marinus Pharmaceuticals (Nasdaq: MRNS) announced topline results from Phase 3 RAISE trial of IV ganaxolone in refractory status epilepticus (RSE). The study met its first co-primary endpoint demonstrating rapid cessation of status epilepticus in a highly refractory patient population but failed to achieve statistical significance on the second co-primary endpoint of the proportion of patients not progressing to IV anesthesia. Marinus said they will continue to analyze the full RAISE dataset and plans to engage with the FDA to discuss a potential path forward for IV ganaxolone in RSE.

On June 4, Viking Therapeutics announced positive, 52-week histologic data from its Phase 2b VOYAGE study of VK2809 in patients with biopsy-confirmed, non-alcoholic steatohepatitis (NASH). The study had successfully achieved its primary endpoint with patients receiving VK2809 experiencing statistically significant declines in liver fat from baseline compared to placebo at 12 weeks. The study also showed an encouraging tolerability and safety profile for VK2809. If development of VK2809 is successful, the program will address a multi-billion dollar market opportunity where Ligand will receive a 3.5% -7.5% royalty on future net sales of VK2809, as well as significant clinical, regulatory, and commercial milestones. Viking plans to schedule an end of Phase 2 meeting with the FDA in the fourth quarter of 2024.

Conference Call and Webcast
Ligand management will host a conference call today beginning at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 715-9871 using the conference ID 8755336. Callers outside the U.S. may dial +1(646) 307-1963. To participate via live or replay webcast, a link is available at View Source