Ligand Reports First Quarter 2022 Financial Results
Ligand Pharmaceuticals reported Q1 2022 financial results with revenue of $45.7 million, down from $55.2 million year-over-year. Despite a 93% increase in royalty revenue to $13.7 million, COVID-19 related Captisol sales declined significantly. The net loss was $(15.4) million, or $(0.91) per share. Ligand reaffirms its 2022 revenue guidance of $147 million to $172 million and adjusted EPS guidance of $1.70 to $2.20, including contributions from OmniAb and COVID-related sales. The planned spin-off of OmniAb through a merger with Avista SPAC is anticipated to close later this year.
- Royalty revenue increased by 93% to $13.7 million.
- Core Captisol sales grew to $6.2 million from $1.3 million year-over-year.
- 2022 revenue guidance reaffirmed at $147 million to $172 million.
- Adjusted earnings per diluted share guidance set at $1.70 to $2.20.
- Total revenue declined from $55.2 million to $45.7 million year-over-year.
- Net loss of $(15.4) million, compared to a net income of $18.1 million in Q1 2021.
- COVID-19 related Captisol sales fell from $30 million to $5.9 million.
Conference Call Begins at
“2022 is off to a strong start with solid financial performance from our growing roster of royalty-bearing products and great execution from all our core technology platforms,” said
First Quarter 2022 Financial Results
Revenue for the first quarter of 2022 was
Cost of Captisol was
Net loss for the first quarter of 2022 was
Ligand repurchased
2022 Financial Guidance
Ligand is reaffirming 2022 revenue guidance for the combined business and providing revenue estimated to be attributable to the OmniAb business anticipating the spin-off later this year. Ligand expects 2022 royalties of
Ligand is introducing full-year 2022 earnings guidance and a breakout of revenue and earnings guidance for the Ligand business excluding OmniAb and COVID-related Captisol. Of the
Update on the OmniAb Separation Process
On
OmniAb will have an initial pre-money equity valuation of
See “Important Information and Where to Find It” and “Participants in the Solicitation” below for additional information regarding the transaction.
First Quarter 2022 and Recent Business Highlights
OmniAb® Platform and Partner Updates
The OmniAb discovery platform provides Ligand’s pharmaceutical industry partners with access to 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™ (BI) 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. Over 55 partners have access to OmniAb-derived antibodies and more than 250 programs are being actively developed or commercialized. As of
In March, Immunovant held an R&D day, where they highlighted Batoclimab (IMVT-1401), an OmniAb-derived monoclonal antibody targeting the neonatal Fc receptor. Immunovant announced plans to initiate a Phase 3 trial in myasthenia gravis in the first half of 2022 with top-line results expected in 2024. Immunovant further outlined plans to initiate clinical trials in four additional indications in 2022, with two of the indications expected to enter directly into pivotal trials. Batoclimab is also being developed by Harbour BioMed in
Aptevo Therapeutics announced that a patient with relapsed/refractory acute myeloid leukemia in an on-going Phase 1b trial received an allogeneic stem cell transplant after receiving APVO436 and experiencing significant reduction in bone marrow blasts. This follows Aptevo's previous announcement that a patient receiving combination therapy is also moving to transplant after one cycle of therapy.
In Q1 and recently, OmniAb entered into new platform licensing agreements with LTZ Therapeutics, Seismic Therapeutics,
Other Portfolio Updates
In March, Travere Therapeutics announced the submission of an NDA to the FDA for accelerated approval of sparsentan for IgA nephropathy (IgAN). Travere announced that plans are underway to submit an NDA for accelerated approval to the FDA for focal segmental glomerulosclerosis (FSGS) and a combined IgAN and FSGS Marketing Authorisation Application in
In April, Merck announced the FDA granted Breakthrough Designation for V116, a 21-valent pneumococcal vaccine utilizing Ligand’s CRM197 vaccine carrier protein produced using the Pelican Expression Technology platform. Merck plans to initiate Phase 3 clinical trials for V116 in 2022.
On
In February, BeiGene, Ltd. announced the launch of KYPROLIS® (carfilzomib) for injection in
Outlook Therapeutics announced it submitted a BLA to the FDA for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration that, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg).
Ligand provides regular updates on 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, 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
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 (BI) 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. We believe 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 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
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. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com.
Important Information and Where to Find It
In connection with the Business Combination and the Distribution, OmniAb has filed with the
The registration statements, proxy statement/prospectus/information statement and other documents (when they are available) will also be available free of charge, at the SEC’s website at www.sec.gov, or by directing a request to:
Participants in the Solicitation
Ligand, APAC and OmniAb, and each of their respective directors, executive officers and other members of their management and employees may be deemed to be participants in the solicitation of proxies from APAC’s shareholders in connection with the Business Combination. Shareholders are urged to carefully read the preliminary proxy statement/prospectus/information statement regarding the Business Combination and the final proxy statement/prospectus/information statement when it becomes available, because it will contain important information. Information regarding the persons who may, under the rules of the
No Solicitation or Offer
This communication shall neither constitute an offer to sell nor the solicitation of an offer to buy any securities, or the solicitation of any proxy, vote, consent or approval in any jurisdiction in connection with the Business Combination, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to any registration or qualification under the securities laws of any such jurisdictions. This communication is restricted by law; it is not intended for distribution to, or use by any person in, any jurisdiction where such distribution or use would be contrary to local law or regulation.
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 expected timing and structure of the Business Combination; the ability of the parties to complete the Business Combination, the expected benefits of the Business Combination; the tax consequences of the Business Combination; the amount of gross proceeds expected to be available to OmniAb after the closing and giving effect to any redemptions by APAC shareholders; OmniAb’s future results of operations and financial position, business strategy and its expectations regarding the application of, and the rate and degree of market acceptance of, the OmniAb technology platform and other technologies; OmniAb’s expectations regarding the addressable markets for our technologies, including the growth rate of the markets in which it operates; the potential for and timing of receipt of milestones and royalties under OmniAb’s license agreements with partners; the timing of product launches by Ligand or its partners; the potential for regulatory approvals of our partners’ product candidates; the timing of the initiation or completion of preclinical studies and clinical trials by Ligand and its partners; and guidance regarding 2022 financial results, including amounts attributable to the OmniAb business, 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; changes in general economic conditions, including as a result of the conflict between
Other Disclaimers and Trademarks
The information in this press release regarding certain third-party products and programs comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs.
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
|
||||||
|
2022 |
|
2021 |
||||
Revenues: |
|
|
|
||||
Royalties |
$ |
13,695 |
|
|
$ |
7,112 |
|
Captisol - Core |
|
6,226 |
|
|
|
1,253 |
|
Captisol - COVID |
|
5,896 |
|
|
|
30,019 |
|
Contract |
|
19,876 |
|
|
|
16,766 |
|
Total revenues |
|
45,693 |
|
|
|
55,150 |
|
Operating costs and expenses: |
|
|
|
||||
Cost of Captisol |
|
4,699 |
|
|
|
8,153 |
|
Amortization of intangibles |
|
11,813 |
|
|
|
11,786 |
|
Research and development |
|
20,307 |
|
|
|
17,879 |
|
General and administrative |
|
18,180 |
|
|
|
12,617 |
|
Total operating costs and expenses |
|
54,999 |
|
|
|
50,435 |
|
Income (loss) from operations |
|
(9,306 |
) |
|
|
4,715 |
|
Gain (loss) from short-term investments |
|
(12,877 |
) |
|
|
13,061 |
|
Interest expense, net |
|
(655 |
) |
|
|
(5,535 |
) |
Other income (expense), net |
|
2,698 |
|
|
|
(6,477 |
) |
Total other income (loss), net |
|
(10,834 |
) |
|
|
1,049 |
|
Income (loss) before income taxes |
|
(20,140 |
) |
|
|
5,764 |
|
Income tax benefit |
|
4,755 |
|
|
|
12,342 |
|
Net income (loss): |
$ |
(15,385 |
) |
|
$ |
18,106 |
|
|
|
|
|
||||
Basic net income (loss) per share |
$ |
(0.91 |
) |
|
$ |
1.10 |
|
Shares used in basic per share calculation |
|
16,824 |
|
|
|
16,435 |
|
|
|
|
|
||||
Diluted net income (loss) per share |
$ |
(0.91 |
) |
|
$ |
1.05 |
|
Shares used in diluted per share calculations |
|
16,824 |
|
|
|
17,248 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in thousands) |
|||||
|
|
|
|
||
ASSETS |
|
|
|
||
Current assets: |
|
|
|
||
Cash, cash equivalents and short-term investments |
$ |
203,999 |
|
$ |
341,108 |
Accounts receivable, net |
|
41,797 |
|
|
85,453 |
Inventory |
|
25,614 |
|
|
27,326 |
Income taxes receivable |
|
— |
|
|
6,193 |
Other current assets |
|
4,656 |
|
|
4,671 |
Total current assets |
|
276,066 |
|
|
464,751 |
Deferred income taxes, net |
|
35,655 |
|
|
34,482 |
|
|
720,913 |
|
|
732,246 |
Commercial license rights, net |
|
10,121 |
|
|
10,110 |
Operating lease right-of-use assets |
|
15,783 |
|
|
16,542 |
Finance lease right-of-use assets |
|
15,620 |
|
|
16,207 |
Other assets |
|
31,026 |
|
|
23,252 |
Total assets |
$ |
1,105,184 |
|
$ |
1,297,590 |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
||
Current liabilities: |
|
|
|
||
Accounts payable and accrued liabilities |
$ |
22,849 |
|
$ |
25,982 |
Income taxes payable |
|
5,800 |
|
|
— |
Current contingent liabilities |
|
1,524 |
|
|
2,588 |
Current operating lease liabilities |
|
1,850 |
|
|
2,053 |
Current finance lease liabilities |
|
52 |
|
|
46 |
Deferred revenue |
|
10,503 |
|
|
10,996 |
Total current liabilities |
|
42,578 |
|
|
41,665 |
2023 convertible senior notes, net |
|
176,540 |
|
|
320,717 |
Long-term contingent liabilities |
|
7,448 |
|
|
8,483 |
Deferred income taxes, net |
|
39,480 |
|
|
59,095 |
Other long-term liabilities |
|
45,946 |
|
|
46,471 |
Total liabilities |
|
311,992 |
|
|
476,431 |
Total stockholders' equity |
|
793,192 |
|
|
821,159 |
Total liabilities and stockholders' equity |
$ |
1,105,184 |
|
$ |
1,297,590 |
SUPPLEMENTAL SEGMENT FINANCIAL RESULTS (Unaudited, in thousands) |
|||||||
|
Three Months Ended
|
||||||
|
2022 |
|
2021 |
||||
OmniAb business revenue |
|
|
|
||||
Royalties |
$ |
263 |
|
|
$ |
— |
|
Contract |
|
8,915 |
|
|
|
8,559 |
|
Total OmniAb business revenue |
|
9,178 |
|
|
|
8,559 |
|
Ligand core business revenue |
|
|
|
||||
Royalties |
|
13,432 |
|
|
|
7,112 |
|
Captisol - Core |
|
6,226 |
|
|
|
1,253 |
|
Captisol - COVID |
|
5,896 |
|
|
|
30,019 |
|
Contract |
|
10,961 |
|
|
|
8,207 |
|
Total Ligand core business revenue |
|
36,515 |
|
|
46,591 |
|
|
Total revenue |
$ |
45,693 |
|
|
$ |
55,150 |
|
|
|
|
|
||||
Segment operating income (loss) |
|
|
|
||||
OmniAb business |
$ |
(6,189 |
) |
|
$ |
(4,604 |
) |
Ligand core business |
|
9,991 |
|
|
|
18,446 |
|
Total segment operating income |
|
3,802 |
|
|
|
13,842 |
|
|
|
|
|
||||
Unallocated corporate items |
|
|
|
||||
Shared-based compensation |
|
5,657 |
|
|
|
4,870 |
|
Other corporate expenses |
|
7,451 |
|
|
|
4,257 |
|
Total unallocated corporate items |
|
13,108 |
|
|
|
9,127 |
|
Income (loss) from operations |
$ |
(9,306 |
) |
|
$ |
4,715 |
|
ADJUSTED FINANCIAL MEASURES (Unaudited, in thousands, except per share amounts) |
|||||||
|
Three months ended
|
||||||
|
2022 |
|
2021(8) |
||||
|
|
|
|
||||
|
|
|
|
||||
Net income (loss) |
$ |
(15,385 |
) |
|
$ |
18,106 |
|
Share-based compensation expense |
|
9,044 |
|
|
|
8,405 |
|
Non-cash interest expense(1) |
|
326 |
|
|
|
4,916 |
|
Amortization related to acquisitions and intangible assets |
|
11,813 |
|
|
|
11,786 |
|
Amortization of commercial license rights(2) |
|
(90 |
) |
|
|
528 |
|
Change in contingent liabilities(3) |
|
(1,034 |
) |
|
|
1,684 |
|
Transaction costs(4) |
|
4,773 |
|
|
|
— |
|
Acquisition and integration costs(5) |
|
— |
|
|
|
422 |
|
Loss (gain) from short-term investments |
|
12,877 |
|
|
|
(13,061 |
) |
Realized gain from short-term investments |
|
(240 |
) |
|
|
3,912 |
|
Other(6) |
|
(1,666 |
) |
|
|
6,089 |
|
Income tax effect of adjusted reconciling items above |
|
(7,306 |
) |
|
|
(6,357 |
) |
Excess tax benefit (windfall) from share-based compensation(7) |
|
17 |
|
|
|
(12,120 |
) |
Adjusted net income |
|
13,129 |
|
|
|
24,310 |
|
Captisol - COVID gross profit, net of tax(8) |
|
(3,094 |
) |
|
|
(21,396 |
) |
Adjusted net income excluding Captisol - COVID |
$ |
10,035 |
|
|
$ |
2,914 |
|
|
|
|
|
||||
Diluted per-share amounts attributable to common shareholders: |
|
|
|
||||
Net income (loss) |
$ |
(0.91 |
) |
|
$ |
1.05 |
|
Share-based compensation expense |
|
0.53 |
|
|
|
0.49 |
|
Non-cash interest expense(1) |
|
0.02 |
|
|
|
0.29 |
|
Amortization related to acquisitions and intangible assets |
|
0.69 |
|
|
|
0.68 |
|
Amortization of commercial license rights(2) |
|
(0.01 |
) |
|
|
0.03 |
|
Change in contingent liabilities(3) |
|
(0.06 |
) |
|
|
0.10 |
|
Transaction costs(4) |
|
0.28 |
|
|
|
— |
|
Acquisition and integration costs(5) |
|
— |
|
|
|
0.02 |
|
Loss (gain) from short-term investments |
|
0.75 |
|
|
|
(0.76 |
) |
Realized gain from short-term investments |
|
(0.01 |
) |
|
|
0.23 |
|
Other(6) |
|
(0.10 |
) |
|
|
0.35 |
|
Income tax effect of adjusted reconciling items above |
|
(0.42 |
) |
|
|
(0.36 |
) |
Excess tax benefit (windfall) from share-based compensation(7) |
|
— |
|
|
|
(0.70 |
) |
Adjusted diluted net income per share |
$ |
0.76 |
|
|
$ |
1.41 |
|
Captisol - COVID gross profit, net of tax(8) |
|
(0.18 |
) |
|
|
(1.27 |
) |
Adjusted diluted net income per share excluding Captisol - COVID |
$ |
0.58 |
|
|
$ |
0.14 |
|
|
|
|
|
||||
GAAP - Weighted average number of common shares-diluted |
|
16,824 |
|
|
|
17,248 |
|
Add: Shares excluded due to anti-dilutive effect on GAAP net loss(9) |
|
369 |
|
|
|
— |
|
Adjusted weighted average number of common shares-diluted |
|
17,193 |
|
|
|
17,248 |
|
(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 rights to revenue.
(3) Amounts represent changes in fair value of contingent consideration related to
(4) Amounts represent incremental costs including primarily legal fees, accounting fees, and advisory fees incurred by Ligand to spin off OmniAb into a standalone, publicly traded company.
(5) Amounts represent severance costs, legal fees and certain contract termination costs in connection with the acquisitions.
(6) Amounts primarily relate to loss on debt extinguishment.
(7) 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
(8) Captisol - COVID gross profit, net of tax, represents gross profit, net of tax, for Captisol supplied for use in formulation with remdesivir, an antiviral treatment for COVID-19. Prior period adjusted net income and adjusted net income per diluted share amount have been adjusted to exclude the impact of COVID-related Captisol gross profit, net of tax, to conform to the current period presentation.
(9) Excluding the impact from the adoption of accounting pronouncement (ASU 2020-06) on
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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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