Ligand Reports Third Quarter 2021 Financial Results
Ligand Pharmaceuticals (NASDAQ: LGND) reported strong Q3 2021 results with total revenues of $64.8 million, a significant increase from $41.8 million in Q3 2020. Royalties rose to $15.6 million, up from $9.0 million, driven by products like Kyprolis and Evomela. Captisol sales surged to $35.1 million, primarily due to COVID-19 treatment demand. Net income was $13.7 million or $0.80 per share compared to a loss of $6.7 million in the same quarter last year. Ligand is also planning a split into two distinct companies to enhance focus on its OmniAb platform and royalty business, aiming for continued growth.
- Total revenues for Q3 2021 were $64.8 million, up from $41.8 million in Q3 2020.
- Royalties increased to $15.6 million, compared to $9.0 million in the prior year.
- Captisol sales rose to $35.1 million, driven by remdesivir demand.
- Net income was $13.7 million, versus a net loss of $6.7 million in Q3 2020.
- Adjusted net income for Q3 2021 was $27.1 million, up from $17.5 million in Q3 2020.
- Ligand reaffirmed its 2021 revenue guidance of $265 million to $275 million.
- Increased costs of goods sold to $50.2 million for the nine months ended September 30, 2021, up from $18.7 million in 2020.
- Research and development expenses rose to $50.8 million, compared to $37.5 million in the same period last year.
- Amortization of intangibles rose significantly to $35.4 million for the nine months ended September 30, 2021, from $11.3 million in 2020.
Conference Call Begins at
“Our business has performed exceptionally well over the past few months, and we are pleased to be reporting excellent third quarter financial results,” said
“As announced separately today, we are pursuing plans to split Ligand into two separate, publicly traded companies with one featuring the OmniAb business, and the other featuring Ligand’s existing collection of core royalties and the technologies, pipeline and contracts associated with the Pelican protein expression platform and the Captisol business,” Higgins added. “Along with outside advisors we have concluded the time is right to pursue this strategic plan and accelerate investment into the OmniAb platform and technologies to further drive value.”
Third Quarter 2021 Financial Results
Total revenues for the third quarter of 2021 were
Cost of Captisol was
Other operating income was
Net income for the third quarter of 2021 was
As of
Year-to-Date Financial Results
Total revenues for the nine months ended
Cost of goods sold was
Other operating income was
Net income for the nine months ended
2021 Financial Guidance
Ligand is reaffirming 2021 financial guidance. Ligand expects full-year 2021 total revenues to be between
Third Quarter 2021 and Recent Business Highlights
OmniAb® Platform Updates
OmniAb is Ligand’s industry-leading BI- (Biological Intelligence™) powered multi-species antibody platform for the discovery of monospecific and bispecific therapeutic human antibodies. As of
Gloria Biosciences received approval from China’s
Aptevo Therapeutics announced positive Phase 1 data showing some patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) achieved a remission with APVO436 after failing 1-8 lines of prior therapies. Data was published in the peer-reviewed journal, Cancers, showing the risk of cytokine release syndrome is low for blood cancer patients treated with APVO436. APVO436 is an OmniAb-derived bispecific antibody targeting CD123 and CD3 for the treatment of hematological malignancies.
Harbour
OmniAb partnered with LandingAI to incorporate an industry leading LandingLens™ visual inspection software platform to strengthen the xPloration™ deep screening platform using AI and computer vision.
During the third quarter, Ligand entered into an OmniAb licensing agreement with
Pelican Platform Updates
The Pelican Expression Technology™ is Ligand's proprietary Pseudomonas fluorescens protein expression technology that has major collaborations with Jazz Pharmaceuticals, Merck,
Merck announced VAXNEUVANCE™ met key immunogenicity and safety endpoints in a Phase 3 pivotal trial evaluating use in infants. The FDA approved VAXNEUVANCE for adults 18 years of age and older in July and Merck has submitted a supplemental regulatory licensure application to the FDA for use in children. On
Jazz Pharmaceuticals announced the National Comprehensive Cancer Network added Rylaze™ to its Clinical Practice Guidelines in Oncology as a treatment option for both pediatric and adult acute lymphoblastic leukemia patients with hypersensitivity to E. coli asparaginase products as a component of the multi-agent chemotherapeutic regimen.
Other
Travere Therapeutics announced positive topline interim results from the ongoing Phase 3 PROTECT study of sparsentan in IgA nephropathy. Sparsentan treatment demonstrated a statistically significant mean reduction of proteinuria from baseline after 36 weeks, more than threefold the reduction of active comparator irbesartan (p<0.0001). Travere met with the FDA for sparsentan in focal segmental glomerulosclerosis (FSGS) confirming plans to submit additional data in the first half of 2022 as part of an accelerated approval submission. Additionally, Travere and Vifor Pharma entered into a licensing agreement for the commercialization of sparsentan in
Ligand entered into a collaboration agreement with China Resources Double-Crane for exclusive
Icagen Ion Channel Technology’s Dr.
In July, Ligand announced the appointment of
Ligand provides regular updates on individual partner events through its Twitter account, @Ligand_LGND.
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, amortization of debt-related costs, 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 and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenues, the Company only provides financial guidance on an adjusted basis and 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, stock-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
About OmniAb®
The OmniAb discovery platform provides Ligand’s pharmaceutical industry partners access to the diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput microfluidic-based single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities to further leverage across modalities, including antibody-drug conjugates and others. The OmniAb suite of technologies and differentiating computational capabilities and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.
About the Pelican Expression Technology™
Pelican is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr.
About
Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. The Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Ab Initio™ technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda,
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: the timing of product launches by Ligand or its partners; the potential for regulatory approvals of our partners’ product candidates; Ligand's plans to pursue a separation of the OmniAb business, including the makeup of the separated and retained businesses and their strategic focus and plans, and the potential to accelerate investment in OmniAb and drive value in each respective business; and guidance regarding 2021 financial results and expectations for near-term and future royalty revenue. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand’s business, including, without limitation: Ligand may not receive expected revenue from royalties, Captisol sales or contract revenue; the COVID-19 pandemic has disrupted and may continue to disrupt Ligand’s and its partners’ business, including delaying manufacturing, preclinical studies and clinical trials and product sales, and impairing global economic activity, all of which could materially and adversely impact Ligand’s results of operations and financial condition; Ligand may not achieve its guidance for 2021; the commercial opportunity for remdesivir could be materially and adversely affected as a result of approved vaccines and alternative approved and investigational therapies, or the FDA revising or revoking its approval; Gilead may develop an alternative formulation of remdesivir that does not incorporate Captisol or uses less Captisol in such formulation; there may not be a market for the product(s) even if successfully developed and approved; Ligand is currently dependent on single source sole supplier for Captisol and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; Amgen,
Other Disclaimers and Trademarks
The information in this press release regarding certain third-party products and programs, including Kyprolis, an Amgen product, and EVOMELA, an
Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand®, Pelican®, Captisol® and OmniAb®. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and ™ symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited, in thousands, except per share amounts) |
|||||||||||||||
|
|
|
|
||||||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
Revenues: |
|
|
|
|
|
|
|
||||||||
Royalties |
$ |
15,648 |
|
|
$ |
9,005 |
|
|
$ |
31,376 |
|
|
$ |
22,751 |
|
Captisol |
35,093 |
|
|
23,389 |
|
|
128,875 |
|
|
68,966 |
|
||||
Contract |
14,094 |
|
|
9,454 |
|
|
44,409 |
|
|
24,712 |
|
||||
Total revenues |
64,835 |
|
|
41,848 |
|
|
204,660 |
|
|
116,429 |
|
||||
Operating costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of Captisol |
11,446 |
|
|
6,353 |
|
|
50,192 |
|
|
18,680 |
|
||||
Amortization of intangibles |
11,827 |
|
|
3,875 |
|
|
35,391 |
|
|
11,285 |
|
||||
Research and development |
16,938 |
|
|
12,853 |
|
|
50,769 |
|
|
37,476 |
|
||||
General and administrative |
12,718 |
|
|
15,020 |
|
|
39,747 |
|
|
34,353 |
|
||||
Other operating income |
(3,800 |
) |
|
— |
|
|
(37,600 |
) |
|
— |
|
||||
Total operating costs and expenses |
49,129 |
|
|
38,101 |
|
|
138,499 |
|
|
101,794 |
|
||||
Income from operations |
15,706 |
|
|
3,747 |
|
|
66,161 |
|
|
14,635 |
|
||||
Gain (loss) from short-term investments |
1,937 |
|
|
(9,862 |
) |
|
8,135 |
|
|
(17,143 |
) |
||||
Interest expense, net |
(4,270 |
) |
|
(5,278 |
) |
|
(14,456 |
) |
|
(13,340 |
) |
||||
Other income (expense), net |
1,886 |
|
|
(219 |
) |
|
(5,516 |
) |
|
1,940 |
|
||||
Total other loss, net |
(447 |
) |
|
(15,359 |
) |
|
(11,837 |
) |
|
(28,543 |
) |
||||
Income (loss) before income taxes |
15,259 |
|
|
(11,612 |
) |
|
54,324 |
|
|
(13,908 |
) |
||||
Income tax benefit (expense) |
(1,536 |
) |
|
4,911 |
|
|
8,230 |
|
|
5,162 |
|
||||
Net income (loss): |
$ |
13,723 |
|
|
$ |
(6,701 |
) |
|
$ |
62,554 |
|
|
$ |
(8,746 |
) |
|
|
|
|
|
|
|
|
||||||||
Basic net income (loss) per share |
$ |
0.82 |
|
|
$ |
(0.42 |
) |
|
$ |
3.77 |
|
|
$ |
(0.54 |
) |
Shares used in basic per share calculation |
16,688 |
|
|
16,082 |
|
|
16,595 |
|
|
16,222 |
|
||||
|
|
|
|
|
|
|
|
||||||||
Diluted net income (loss) per share |
$ |
0.80 |
|
|
$ |
(0.42 |
) |
|
$ |
3.64 |
|
|
$ |
(0.54 |
) |
Shares used in diluted per share calculations |
17,142 |
|
|
16,082 |
|
|
17,187 |
|
|
16,222 |
|
||||
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in thousands) |
|||||||
|
|
|
|
||||
ASSETS |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash, cash equivalents and short-term investments |
$ |
323,211 |
|
|
$ |
411,186 |
|
Accounts receivable, net |
64,336 |
|
|
56,847 |
|
||
Inventory |
32,996 |
|
|
26,487 |
|
||
Income taxes receivable |
6,378 |
|
|
2,217 |
|
||
Other current assets |
5,161 |
|
|
3,822 |
|
||
Total current assets |
432,082 |
|
|
500,559 |
|
||
Deferred income taxes, net |
26,728 |
|
|
24,320 |
|
||
|
752,555 |
|
|
784,992 |
|
||
Commercial license and other economic rights, net |
10,748 |
|
|
10,979 |
|
||
Operating lease right-of-use assets |
12,951 |
|
|
6,892 |
|
||
Finance lease right-of-use assets |
16,795 |
|
|
15,842 |
|
||
Other assets |
21,797 |
|
|
18,701 |
|
||
Total assets |
$ |
1,273,656 |
|
|
$ |
1,362,285 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable and accrued liabilities |
$ |
19,470 |
|
|
$ |
22,314 |
|
Current contingent liabilities |
2,594 |
|
|
39,884 |
|
||
Current operating lease liabilities |
2,181 |
|
|
1,885 |
|
||
Current finance lease liabilities |
45 |
|
|
6,593 |
|
||
Deferred revenue |
12,007 |
|
|
29,435 |
|
||
Total current liabilities |
36,297 |
|
|
100,111 |
|
||
2023 convertible senior notes, net |
316,889 |
|
|
442,293 |
|
||
Long-term contingent liabilities |
6,782 |
|
|
9,249 |
|
||
Deferred income taxes, net |
63,026 |
|
|
64,598 |
|
||
Other long-term liabilities |
38,596 |
|
|
36,509 |
|
||
Total liabilities |
461,590 |
|
|
652,760 |
|
||
Total stockholders' equity |
812,066 |
|
|
709,525 |
|
||
Total liabilities and stockholders' equity |
$ |
1,273,656 |
|
|
$ |
1,362,285 |
|
ADJUSTED FINANCIAL MEASURES (Unaudited, in thousands, except per share amounts) |
|||||||||||||||
|
|
|
|
||||||||||||
|
Three months ended
|
|
Nine months ended
|
||||||||||||
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
||||
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
||||||||
Net income (loss) |
$ |
13,723 |
|
|
$ |
(6,701 |
) |
|
$ |
62,554 |
|
|
$ |
(8,746 |
) |
Share-based compensation expense |
|
9,754 |
|
|
|
7,740 |
|
|
|
28,375 |
|
|
|
20,752 |
|
Non-cash interest expense(1) |
|
3,791 |
|
|
|
5,301 |
|
|
|
12,864 |
|
|
|
17,743 |
|
Amortization related to acquisitions and intangible assets |
|
11,827 |
|
|
|
3,875 |
|
|
|
35,391 |
|
|
|
11,285 |
|
Amortization of commercial license and other economic rights(2) |
|
(190 |
) |
|
|
(228 |
) |
|
|
151 |
|
|
|
3,277 |
|
Change in contingent liabilities(3) |
|
(5,875 |
) |
|
|
(28 |
) |
|
|
(39,377 |
) |
|
|
(384 |
) |
Acquisition and integration costs(4) |
|
68 |
|
|
|
4,956 |
|
|
|
511 |
|
|
|
4,956 |
|
Loss (gain) from short-term investments |
|
(1,937 |
) |
|
|
9,862 |
|
|
|
(8,135 |
) |
|
|
17,143 |
|
Realized gain from short-term investments |
|
359 |
|
|
|
1,811 |
|
|
|
5,740 |
|
|
|
761 |
|
Other(5) |
|
191 |
|
|
|
687 |
|
|
|
8,839 |
|
|
|
1,070 |
|
Income tax effect of adjusted reconciling items above |
|
(5,202 |
) |
|
|
(9,610 |
) |
|
|
(14,734 |
) |
|
|
(17,315 |
) |
Excess tax benefit from share-based compensation(6) |
|
579 |
|
|
|
(172 |
) |
|
|
(12,749 |
) |
|
|
(1,113 |
) |
Adjusted net income |
|
27,088 |
|
|
|
17,494 |
|
|
|
79,430 |
|
|
|
49,430 |
|
Diluted per-share amounts attributable to common shareholders: |
|
|
|
|
|
|
|
||||||||
Net income (loss) |
$ |
0.80 |
|
|
$ |
(0.42 |
) |
|
$ |
3.64 |
|
|
$ |
(0.54 |
) |
Share-based compensation expense |
|
0.57 |
|
|
|
0.48 |
|
|
|
1.65 |
|
|
|
1.28 |
|
Non-cash interest expense(1) |
|
0.22 |
|
|
|
0.33 |
|
|
|
0.75 |
|
|
|
1.09 |
|
Amortization related to acquisitions and intangible assets |
|
0.69 |
|
|
|
0.24 |
|
|
|
2.06 |
|
|
|
0.70 |
|
Amortization of commercial license and other economic rights(2) |
|
(0.01 |
) |
|
|
(0.01 |
) |
|
|
0.01 |
|
|
|
0.20 |
|
Change in contingent liabilities(3) |
|
(0.34 |
) |
|
|
— |
|
|
|
(2.29 |
) |
|
|
(0.02 |
) |
Acquisition and integration costs(4) |
|
— |
|
|
|
0.31 |
|
|
|
0.03 |
|
|
|
0.31 |
|
Loss (gain) from short-term investments |
|
(0.11 |
) |
|
|
0.61 |
|
|
|
(0.47 |
) |
|
|
1.06 |
|
Realized gain from short-term investments |
|
0.02 |
|
|
|
0.11 |
|
|
|
0.33 |
|
|
|
0.05 |
|
Other(5) |
|
0.01 |
|
|
|
0.04 |
|
|
|
0.51 |
|
|
|
0.07 |
|
Income tax effect of adjusted reconciling items above |
|
(0.30 |
) |
|
|
(0.59 |
) |
|
|
(0.86 |
) |
|
|
(1.08 |
) |
Excess tax benefit from share-based compensation(6) |
|
0.03 |
|
|
|
(0.01 |
) |
|
|
(0.74 |
) |
|
|
(0.07 |
) |
Adjustment for shares excluded due to anti-dilution effect on GAAP net loss |
|
— |
|
|
|
(0.05 |
) |
|
|
— |
|
|
|
(0.12 |
) |
Adjusted net income |
$ |
1.58 |
|
|
$ |
1.04 |
|
|
$ |
4.62 |
|
|
$ |
2.93 |
|
|
|
|
|
|
|
|
|
||||||||
GAAP - Weighted average number of common shares-diluted |
|
17,142 |
|
|
|
16,082 |
|
|
|
17,187 |
|
|
|
16,222 |
|
Add: Shares excluded due to anti-dilutive effect on GAAP net loss |
|
— |
|
|
|
703 |
|
|
|
— |
|
|
|
651 |
|
Adjusted weighted average number of common shares-diluted |
|
17,142 |
|
|
|
16,785 |
|
|
|
17,187 |
|
|
|
16,873 |
|
(1) Amounts represent non-cash debt related costs that are calculated in accordance with the authoritative accounting guidance for convertible debt instruments that may be settled in cash. |
|
(2) Amounts represent the amortization of commercial license and other economic rights to revenue and research and development expenses. |
|
(3) Amounts represent changes in fair value of contingent consideration related to |
|
(4) Amounts represent severance costs, legal fees and certain contract termination costs in connection with the acquisitions. |
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(5) Amounts primarily relate to loss on debt extinguishment. |
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(6) Excess tax benefits from share-based compensation are recorded as a discrete item within the provision for income taxes on the consolidated statement of operations as a result of the adoption of an accounting pronouncement (ASU 2016-09) on |
View source version on businesswire.com: https://www.businesswire.com/news/home/20211109006417/en/
Email: investors@ligand.com
Phone: (858) 550-7766
Twitter: @Ligand_LGND
LHA Investor Relations
Email: bvoss@lhai.com
Phone: (310) 691-7100
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