On November 7, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three and nine months ended September 30, 2022 and provided operating and program updates (Press release, Ligand, NOV 7, 2022, View Source [SID1234623306]). Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.
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"The past quarter was a strong period of positive portfolio updates and financial performance for Ligand. We are pleased to be moving forward now focused on growing revenue and cash flows of our existing portfolio and reporting on late-stage developments from our high-value partnerships over the next few quarters."
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"This quarter was focused on one of the most transformative transactions in Ligand’s history, the spin-off of our OmniAb antibody discovery business. I am excited for what lies ahead for Ligand and OmniAb as both execute their strategic goals as independent, publicly traded companies," said John Higgins, CEO of Ligand. "The past quarter was a strong period of positive portfolio updates and financial performance for Ligand. We are pleased to be moving forward now focused on growing revenue and cash flows of our existing portfolio and reporting on late-stage developments from our high-value partnerships over the next few quarters."
Third Quarter 2022 Financial Results
Revenue for the third quarter of 2022 was $66.1 million, compared with $64.8 million for the same period in 2021. Royalty revenue increased by 27% to $19.8 million due primarily to Kyprolis, Rylaze and Teriparatide. Core Captisol sales for the third quarter of 2022 were $3.6 million, compared with $5.4 million for the same period in 2021. The difference in sales is due to timing of customer orders. Captisol sales related to COVID-19 were $32.4 million for the third quarter of 2022, compared with $29.7 million for the same period in 2021. Contract revenue for the third quarter of 2022 was $10.3 million compared with $14.1 million for the same period in 2021. The difference is due to the timing of partner milestone events. Revenue attributable to the OmniAb business for the third quarter of 2022 was $6.9 million, compared with $5.1 million for the prior-year period.
Cost of Captisol was $14.2 million for the third quarter of 2022, compared with $11.4 million for the same period in 2021, with the increase primarily due to higher total sales of Captisol and a shift in the mix of Captisol sales this quarter away from clinical use customers. Amortization of intangibles was $11.8 million for the third quarter of both 2022 and 2021. Research and development expense was $22.0 million for the third quarter of 2022, compared with $16.9 million for the same period in 2021, with the increase primarily due to continued investment in the OmniAb business including facilities and headcount related expenditures in preparation for the spin-off. General and administrative expense was $17.4 million for the third quarter of 2022, compared with $12.7 million for the same period in 2021, with the increase primarily due to headcount related expenditures at OmniAb in preparation for the spin-off.
There was no other operating income for the third quarter of 2022, compared with $3.8 million for the third quarter of 2021, which represented a non-cash valuation adjustment related to eliminating the remaining Pfenex CVR liability.
Net income for the third quarter of 2022 was $0.4 million, or $0.02 per diluted share, compared with net income of $13.7 million, or $0.80 per diluted share, for the same period in 2021. Net income for the third quarter of 2022 included a $0.9 million net non-cash loss from the value of Ligand’s short-term investments, and net income for the third quarter of 2021 included a $1.6 million net non-cash gain from the value of Ligand’s short-term investments. Adjusted net income for the third quarter of 2022 was $22.5 million, or $1.31 per diluted share, compared with $27.1 million, or $1.58 per diluted share, for the same period in 2021. Excluding the impact of gross profit, net of tax, for Captisol sales related to COVID-19, adjusted net income for the third quarter of 2022 was $7.1 million, or $0.41 per diluted share, compared with $10.9 million, or $0.64 per diluted share, for the same period in 2021. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.
Ligand repurchased $38.6 million in principal amount of its 2023 Notes for $37.7 million in cash during the third quarter of 2022. $76.9 million in principal amount of the 2023 Notes were outstanding as of September 30, 2022 and will mature in May 2023. As of September 30, 2022, Ligand had cash, cash equivalents and short-term investments of $121.4 million.
Year-to-Date Financial Results
Revenue for the nine months ended September 30, 2022 was $169.2 million, compared with $204.7 million for the same period in 2021. Royalties for the nine months ended September 30, 2022 were $51.5 million, compared with $31.4 million for the same period in 2021, with the increase due primarily to Kyprolis, Rylaze and Teriparatide. Core Captisol sales for the nine months ended September 30, 2022 were $13.1 million, compared with $16.3 million for the same period in 2021. The difference in sales is due to timing of customer orders. Captisol sales related to COVID-19 were $64.5 million for the nine months ended September 30, 2022, compared with $112.6 million for the same period in 2021. The lower sales are due to reduced demand for the pandemic-related treatment. Contract revenue was $40.1 million for the nine months ended September 30, 2022, compared with $44.4 million for the same period in 2021, with the change due to the timing of partner milestone events. Revenue attributable to the OmniAb business for the nine months ended September 30, 2022 was $23.3 million, compared with $19.5 million for the prior-year period.
Cost of Captisol was $31.2 million for the nine months ended September 30, 2022, compared with $50.2 million for the same period in 2021, with the decrease primarily due to lower total sales of Captisol. Amortization of intangibles for the nine months ended September 30, 2022 was $35.5 million, compared with $35.4 million for the same period in 2021. Research and development expense was $61.5 million for the nine months ended September 30, 2022, compared with $50.8 million for the same period of 2021, with the increase primarily due to continued investment in the OmniAb business including facilities and headcount related expenditures in preparation for the spin-off. General and administrative expense was $50.2 million for the nine months ended September 30, 2022, compared with $39.7 million expense for the same period in 2021, with the increase primarily due to transaction costs in connection with the spin-off of OmniAb and other headcount related expenditures at OmniAb, and additional legal expenses incurred during the nine months ended September 30, 2022.
There was no other operating income for the nine months ended September 30, 2022, compared with $37.6 million for the nine months ended September 30, 2021, which represented a non-cash valuation adjustment related to eliminating the remaining Pfenex CVR liability.
Net loss for the nine months ended September 30, 2022 was $15.9 million, or $0.94 per share, compared with net income of $62.6 million, or $3.64 per diluted share, for the same period in 2021. Net loss for the nine months ended September 30, 2022 included a $15.4 million net non-cash loss from the value of Ligand’s short-term investments, while net income for the same period in 2021 included a $37.6 million non-cash valuation adjustment related to eliminating the Pfenex CVR liability and a $2.4 million net non-cash gain from the value of Ligand’s short-term investments. Adjusted net income for the nine months ended September 30, 2022 was $53.2 million, or $3.11 per diluted share, compared with $79.4 million, or $4.62 per diluted share, for the same period in 2021. Excluding the impact of gross profit, net of tax, for Captisol sales related to COVID-19, adjusted net income for the nine months ended September 30, 2022 was $22.9 million, or $1.33 per diluted share, compared with $26.9 million, or $1.56 per diluted share, for the same period in 2021. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.
2022 Financial Guidance
Ligand is increasing 2022 financial guidance from continuing operations. Following closing of the spin-off, OmniAb will now be accounted for as discontinued operations which will result in OmniAb being excluded from Ligand’s reported revenue and adjusted earnings in all subsequent financial statement periods, therefore, the financial outlook below excludes contributions from OmniAb.
We now expect total revenue of $184 million to $189 million, compared to previous guidance of $133 million to $146 million. Ligand now expects 2022 royalties of $66 million to $69 million, Captisol sales of approximately $100 million and contract revenue of $18 million to $20 million. Of the $100 million of expected Captisol sales, Ligand expects approximately $15 million to be attributable to core Captisol sales, and the balance to be attributable to treatments for COVID-19. Excluding COVID-related Captisol sales, Ligand expects revenue to be $99 million to $104 million and adjusted earnings per diluted share to be $2.05 to $2.20. Ligand expects the contribution from COVID-related Captisol sales to be approximately $2.25 per diluted share, resulting in a total company adjusted earnings per diluted share of $4.30 to $4.45.
Analyst and Investor Day
Ligand also provided details of its upcoming analyst and investor day, which will be held in-person in New York City on Tuesday December 13, with a virtual connection option as well. Company presenters will include John Higgins, CEO, Matt Korenberg, President and COO and Tavo Espinoza, CFO. Additional details will be announced at a later date. For more information or to RSVP, please contact Simon Latimer at [email protected].
Third Quarter 2022 and Recent Business Highlights
On November 1, 2022, Ligand completed the tax-free spin-off of OmniAb, Inc., its antibody discovery business. On November 2, 2022 OmniAb began regular-way trading on NASDAQ under the ticker symbol "OABI". Ligand continues to trade under the ticker symbol "LGND".
Travere Therapeutics announced that the previously assigned PDUFA target action date of November 17, 2022 for its NDA under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN) is expected to be extended by three months and is now February 17, 2023. Travere subsequently announced the European Medicines Agency has accepted for review the Conditional Marketing Authorization for sparsentan for IgAN in Europe with a review decision expected in the second half of 2023.
Verona Pharma announced positive top-line results from its Phase 3 ENHANCE-2 trial evaluating ensifentrine for the treatment of COPD. The trial successfully met its primary and secondary endpoints evaluating lung function, and significantly reduced the rate and risk of COPD exacerbations. Ensifentrine was well tolerated with safety results similar to placebo. Verona subsequently announced additional analyses demonstrating ensifentrine reduced exacerbation rates across all subgroups in the Phase 3 ENHANCE-2 trial.
Merck announced the European Medicines Agency has recommended approval of VAXNEUVANCE for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in individuals from 6 weeks to less than 18 years of age. VAXNEUVANCE is a 15-valent pneumococcal vaccine utilizing Ligand’s CRM197 vaccine carrier protein and is currently authorized for use in the European Union for individuals 18 years of age and older and is approved in the United States for individuals 6 weeks of age and older. In July 2022 Merck started a broad Phase 3 program for V116, their investigational 21-valent pneumococcal conjugate vaccine utilizing Ligand’s CRM197 vaccine carrier protein.
Sermonix Pharmaceuticals announced results of its ELAINE 1 Phase 2 study of lasofoxifene vs. fulvestrant in postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer and an ESR1 mutation. Median progression-free survival was 6.04 months for lasofoxifene vs. 4.04 months for fulvestrant (p=0.138). Objective response rate was 13.2% for lasofoxifene vs. 2.9% for fulvestrant, (p=0.12), with 1 complete response and 4 partial responses in the lasofoxifene arm vs. no complete responses and 1 partial response in the fulvestrant arm. While the study was not powered for statistical significance, all endpoints numerically favored lasofoxifene.
Adjusted Financial Measures
The Company 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, non-cash interest expense, amortization related to acquisitions and intangible 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, gross profit for Captisol sales related to COVID-19, net of tax, transaction costs 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 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.
Conference Call
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 (646) 960-0369 and use conference ID 6501694. To participate via live or replay webcast, a link is available at www.ligand.com.