S-BEES-BUMBLEBEE
4年前
Ligand Announces Record Date and Details for Distribution for OmniAb Spin-Off
October 03 2022 - 09:00AM
Business Wire
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its board of directors has set October 26, 2022 as the record date (Record Date) for the dividend of shares of common stock of OmniAb, Inc. to be distributed to Ligand shareholders in order to effect the separation of Ligand and OmniAb into two independent, publicly traded companies. The dividend in OmniAb shares is expected to be distributed to Ligand shareholders on or about November 1, 2022, the expected closing date of the previously announced business combination (Business Combination) between OmniAb and Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA). Following the closing of the Business Combination, APAC will change its name to “OmniAb, Inc.” (New OmniAb) and begin trading on the Nasdaq Global Market under the stock ticker symbol “OABI,” and Ligand will continue to trade on the Nasdaq Global Market under the stock ticker symbol “LGND.”
Ligand shareholders as of the close of business on the Record Date will receive shares of OmniAb common stock on a pro rata basis representing 100% of Ligand’s interest in OmniAb. Immediately following the distribution of OmniAb shares, the Business Combination is expected to close. Upon the closing of the Business Combination, all shares of OmniAb common stock will be automatically exchanged for shares of New OmniAb on a pro rata basis according to a base exchange ratio (Base Exchange Ratio) calculated immediately prior to closing using a formula set forth in the merger agreement (Merger Agreement) among Ligand, OmniAb, APAC and a subsidiary of APAC. The Base Exchange Ratio is based on the number of shares of Ligand common stock outstanding and the relative trading values of the Ligand common stock in the “regular way” and “ex-distribution” markets during the five-trading-day period prior to the closing.
Based on an illustrative record date of June 30, 2022 and Ligand stock price as of such date and an estimated Base Exchange Ratio, Ligand shareholders would receive approximately 4.9 shares of New OmniAb common stock for each share of Ligand/OmniAb common stock.
In addition, as part of the exchange, Ligand shareholders as of the Record Date will receive earnout shares (Earnout Shares) of New OmniAb common stock on a pro rata basis according to an earnout exchange ratio (Earnout Exchange Ratio) calculated immediately prior to closing using a formula set forth in the Merger Agreement. Based on an illustrative record date of June 30, 2022 and Ligand stock price as of such date and an estimated Earnout Exchange Ratio, Ligand shareholders would receive approximately 0.75 shares of New OmniAb common stock for each share of Ligand/OmniAb common stock. The Earnout Shares will vest based upon the achievement of certain volume-weighted average trading prices for shares of New OmniAb during the five-year period following the closing of the Business Combination.
Based on the foregoing estimates, Ligand’s shareholders would receive aggregate shares of New OmniAb common stock representing approximately 76.3% (assuming no redemptions by APAC shareholders) to 85.0% (assuming maximum redemptions by APAC shareholders) of New OmniAb, APAC’s existing public shareholders would own approximately 18.0% (assuming no redemptions by APAC shareholders) to 0% (assuming maximum redemptions by APAC shareholders) of New OmniAb, and the sponsor and related parties of APAC (Sponsor) would own approximately 5.7% (assuming no redemptions by APAC shareholders) to 15.0% (assuming maximum redemptions by APAC shareholders) of New OmniAb, including the Earnout Shares in each case.
The actual number of shares of New OmniAb common stock and Earnout Shares that each Ligand shareholder will receive with respect to each share of OmniAb common stock will be calculated on the closing date and may differ from these estimates. No fractional shares of New OmniAb common stock will be issued in the merger, and instead Ligand shareholders will receive cash in lieu of any fractional share (other than with respect to Earnout Shares).
Ligand shareholders do not need to take any action. Their OmniAb shares received upon distribution of the dividend will automatically be exchanged for New OmniAb common stock and Earnout Shares in the merger on the closing date of the Business Combination. Following the closing of the Business Combination, Ligand shareholders will continue to hold, along with their new shares of New OmniAb common stock and Earnout Shares, the same number of shares of Ligand common stock that they held immediately prior to the closing. After the closing, investors should expect that Ligand’s share price will adjust to reflect the transfer of the OmniAb business to New OmniAb.
In connection with the Business Combination, OmniAb and APAC filed registration statements with the Securities and Exchange Commission (SEC), described below under “Important Information and Where to Find It.” On September 30, 2022, the SEC declared both registration statements effective. The registration statements contain further information regarding the spin-off and Business Combination, including the conditions to completion of the Business Combination and additional details regarding the calculation of the applicable exchange ratios described above.
Factors that May Affect the Dividend and Spin-Off
The dividend is conditioned upon, and the spin-off and Business Combination are subject to, the satisfaction or waiver of closing conditions for the Business Combination. If certain closing conditions are not satisfied or waived in advance of the expected closing date, Ligand may elect to change the record date for the dividend to a later date or to not proceed with the dividend or the spin-off.
Two-Way Trading to Begin for Ligand on the Nasdaq Global Market (Nasdaq)
Beginning on or around the trading day prior to the Record Date and continuing through the close of trading on the closing date of the Business Combination, there will be two markets in Ligand common stock on Nasdaq: a “regular way” market and an “ex-distribution” market. During this period of two-way trading in Ligand common stock, there will also be a market on Nasdaq for New OmniAb common stock on a “when issued” basis.
The trading options that will be available during the two-way trading period are:
Ligand Regular Way Trading
If, during the period of two-way trading, a Ligand shareholder sells a share of Ligand common stock in the regular way market under Ligand’s Nasdaq symbol, “LGND,” the shareholder will be selling both the share of Ligand common stock and the right to receive shares of New OmniAb common stock in the transaction.
Ligand Ex-distribution Trading
If, during the period of two-way trading, a Ligand shareholder sells a share of Ligand common stock in the ex-distribution market under the temporary Nasdaq symbol “LGNDV,” the Ligand shareholder will be selling only a share of Ligand common stock and will retain the right to receive shares of New OmniAb common stock in the transaction.
New OmniAb When issued Trading
During the two-way trading period, a Ligand shareholder also has the option of selling the right to receive shares of New OmniAb common stock while retaining shares of Ligand common stock. This option will be available under the temporary Nasdaq symbol “OABIV.”
Trades under the symbols “OABIV” and “LGNDV” will settle after the closing date of the Business Combination. If the transaction is not completed, all trades made under these temporary symbols will be cancelled.
In all cases, investors should consult with their financial and tax advisors regarding the specific implications of selling shares of their Ligand common stock or the right to receive shares of New OmniAb common stock on or before the closing date of the Business Combination.
About OmniAb®
OmniAb’s discovery platform provides 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 the 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 phenotypic screening and mining of next-generation sequencing datasets with custom algorithms 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 in emerging target classes. OmniAb antibodies have been leveraged across modalities, including bispecific antibodies, antibody-drug conjugates and others. The OmniAb suite of technologies span from BI-powered repertoire generation to cutting edge antibody discovery and optimization offering a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.
About Avista Public Acquisition Corp. II
APAC is a special purpose acquisition company that completed its initial public offering in August 2021. APAC was formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or business combination with one or more businesses. APAC is sponsored by Avista Acquisition LP II, which was formed for the express purpose of acting as the sponsor for APAC. Avista Acquisition Corp. is an affiliate of Avista Capital Holdings, L.P. For more information, please visit www.avistapac.com/ahpac.
About Ligand Pharmaceuticals
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, Takeda, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com.
Follow Ligand on Twitter @Ligand_LGND.
Important Information and Where to Find It
In connection with the Business Combination, OmniAb filed with the SEC a registration statement on Form 10 (Form 10) (File No. 000-56427) registering shares of OmniAb Common Stock and APAC filed with the SEC a registration statement on Form S-4 (Form S-4) (File No. 333-264525) registering shares of New OmniAb Common Stock, warrants and certain equity awards. APAC has also filed a definitive proxy statement/prospectus in connection with the APAC shareholder vote required in connection with the Business Combination. The Form 10 filed by OmniAb included portions of the Form S-4 filed by APAC, which will serve as an information statement/prospectus in connection with the spin-off of OmniAb. This communication does not contain all the information that should be considered concerning the Business Combination. This communication is not a substitute for the registration statements that OmniAb and APAC filed or will file with the SEC or any other documents that APAC or OmniAb may file with the SEC, or that APAC, Ligand or OmniAb may send to stockholders in connection with the Business Combination. It is not intended to form the basis of any investment decision or any other decision in respect to the Business Combination. APAC’s shareholders, Ligand’s stockholders and other interested persons are advised to read the definitive registration statements, and documents incorporated by reference therein, as these materials will contain important information about APAC, OmniAb and the Business Combination. The definitive proxy statement/prospectus will be mailed to APAC’s shareholders as of the record date of September 1, 2022 for voting on the Business Combination.
The registration statements, proxy statement/prospectus/information statement and other documents are also available free of charge at the SEC’s website at www.sec.gov or by directing a request to: Avista Public Acquisition Corp. II, 65 East 55th Street, 18th Floor, New York, NY 10022.
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 final proxy statement/prospectus/information statement because it contains important information. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of APAC’s shareholders in connection with the Business Combination is set forth in the registration statements filed with the SEC. Information about APAC’s executive officers and directors and OmniAb’s management and directors also is set forth in the registration statements relating to the Business Combination.
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: the expected timing of the spin-off of OmniAb and Business Combination with APAC; the estimated Base Exchange Ratio and Earnout Exchange Ratio and aggregate ownership of New OmniAb by Ligand’s and APAC’s respective shareholders and by the Sponsor; the anticipated two-way trading market in Ligand common stock on Nasdaq and when-issued trading in New OmniAb common stock; and the ability of the parties to complete the proposed transaction. Actual events or results may differ from Ligand’s expectations due to risks and uncertainties inherent in Ligand’s business, including, without limitation: the Business Combination may not be completed in accordance with the expected plans or anticipated timeline or at all; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at www.sec.gov.
The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of APAC’s registration statement on Form S-1 (File No. 333-257177), the registration statement on Form S-4 (File No. 333-264525), the registration statement on Form 10 (File No. 000-56427), the proxy/information statement/prospectus and certain other documents filed or that may be filed by APAC, Ligand or OmniAb from time to time with the SEC following the date hereof. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ligand, OmniAb and APAC assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Neither Ligand, OmniAb, or APAC gives any assurance that Ligand, OmniAb or APAC will achieve their expectations. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221003005364/en/
Ligand Pharmaceuticals Incorporated
Simon Latimer
investors@ligand.com
(858) 550-7766
Twitter: @Ligand_LGND
LHA Investor Relations
Bruce Voss
bvoss@lhai.com
(310) 691-7100
S-BEES-BUMBLEBEE
4年前
Ligand Reports Second Quarter 2022 Financial Results
August 08 2022 - 04:01PM
Business Wire
Raises 2022 Financial Guidance
Conference Call Begins at 4:30 p.m. Eastern Time Today
Ligand Pharmaceuticals Incorporated (NASDAQ: $LGND) today reported financial results for the three and six months ended June 30, 2022 and provided an operating forecast and program updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.
“2022 continues to be an outstanding year for Ligand, in particular as royalties from our Pelican Expression Technology platform grow into meaningful revenue contributors,” said John Higgins, CEO of Ligand. “The business is enjoying good momentum with numerous positive late-stage developments announced by our partners this past quarter. Financially, the business is doing very well, and we are solidly positioned to spin-off the expanding OmniAb business through a distribution to shareholders and merger with the Avista SPAC expected to close in the fourth quarter of this year."
Second Quarter 2022 Financial Results
Revenue for the second quarter of 2022 was $57.4 million, compared with $84.7 million for the same period in 2021. Royalty revenue increased 108% to $18.0 million due primarily to Kyprolis and sales of products using the Pelican platform. Core Captisol sales for the second quarter of 2022 were $3.3 million, compared with $9.7 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 $26.2 million for the second quarter of 2022, compared with $52.8 million for the same period in 2021. The difference in sales is due to reduced demand for the pandemic-related treatment. Contract revenue was $9.9 million, lower than the same period last year which included two significant milestones tied to the Pelican platform. Revenue attributable to the OmniAb business for the second quarter of 2022 was $7.3 million, compared with $5.8 million for the prior year period.
Cost of Captisol was $12.4 million for the second quarter of 2022, compared with $30.6 million for the same period in 2021, with the decrease primarily due to lower total sales of Captisol. Amortization of intangibles was $11.8 million for the second quarter of both 2022 and 2021. Research and development expense was $19.1 million for the second quarter of 2022, compared with $16.0 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 associated with the expected spin-off later this year. General and administrative expense was $14.6 million for the second quarter of 2022, compared with $14.7 million for the same period in 2021.
There was no other operating income for the second quarter of 2022, compared with $34.1 million for the second quarter of 2021, which represented a non-cash valuation adjustment to reduce the Pfenex CVR liability due to an expected lower probability of achieving the required milestone under the Pfenex CVR Agreement.
Net loss for the second quarter of 2022 was $(0.9) million, or $(0.05) per share, compared with net income of $30.7 million, or $1.79 per diluted share, for the same period in 2021. Net loss for the second quarter of 2022 included a $(1.9) million net non-cash loss from the value of Ligand’s short-term investments, and net income for the second quarter of 2021 included a $(8.3) million net non-cash loss from the value of Ligand’s short-term investments. Adjusted net income for the second quarter of 2022 was $17.6 million, or $1.03 per diluted share, compared with $28.0 million, or $1.63 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 second quarter of 2022 was $5.7 million, or $0.34 per diluted share, compared with $13.0 million, or $0.76 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 $62.0 million in principal amount of its 2023 Notes for $60.0 million in cash during the second quarter of 2022. As of June 30, 2022, Ligand had cash, cash equivalents and short-term investments of $147.9 million.
Year-to-Date Financial Results
Revenue for the six months ended June 30, 2022 was $103.1 million, compared with $139.8 million for the same period in 2021. Royalties for the six months ended June 30, 2022 were $31.7 million, compared with $15.7 million for the same period in 2021, with the increase due primarily to Kyprolis and sales of products using the Pelican platform. Core Captisol sales for the six months ended June 30, 2022 were $9.6 million, compared with $10.9 million for the prior year. Captisol sales related to COVID-19 were $32.1 million for the six months ended June 30, 2022, compared with $82.8 million for the same period in 2021. The lower sales are due to reduced demand for the pandemic-related treatment. Contract revenue was $29.8 million for the six months ended June 30, 2022, compared with $30.3 million for the same period in 2021.
Cost of Captisol was $17.1 million for the six months ended June 30, 2022, compared with $38.7 million for the same period in 2021, with the decrease primarily due to lower total sales of Captisol. Amortization of intangibles for both the six months ended June 30, 2022 and 2021 was $23.6 million. Research and development expense was $39.4 million for the six months ended June 30, 2022, compared with $33.8 million for the same period of 2021, with the increase primarily due to continued investment in the OmniAb business which includes facilities and headcount related expenditures associated with the expected spin-off later this year. General and administrative expense was $32.8 million for the six months ended June 30, 2022, compared with $27.0 million expense for the same period in 2021, with the increase primarily due to $5.0 million in transaction costs incurred during the six months ended June 30, 2022 in connection with the planned spin-off of OmniAb.
There was no other operating income for the six months ended June 30, 2022, compared with $33.8 million for the six months ended June 30, 2021, which represented a non-cash valuation adjustment to reduce the Pfenex CVR liability due to an expected lower probability of achieving the required milestone under the Pfenex CVR Agreement.
Net loss for the six months ended June 30, 2022 was $(16.3) million, or $(0.97) per share, compared with net income of $48.8 million, or $2.84 per diluted share, for the same period in 2021. Net loss for the six months ended June 30, 2022 included a $(14.5) 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 $0.8 million net non-cash gain from the value of Ligand’s short-term investments. Adjusted net income for the six months ended June 30, 2022 was $30.7 million, or $1.79 per diluted share, compared with $52.3 million, or $3.04 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 six months ended June 30, 2022 was $15.8 million, or $0.92 per diluted share, compared with $15.9 million, or $0.93 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 raising 2022 revenue guidance for the combined business and is reaffirming revenue estimated to be attributable to the OmniAb business anticipating the spin-off occurs later this year. Ligand expects 2022 royalties of $62 million to $66 million, Captisol sales of $55 million to $60 million and contract revenue of $52 million to $62 million. These revenue components result in total revenue of $169 million to $188 million for the combined business. Ligand expects that $35 million to $45 million of revenue will be attributable to OmniAb, principally in the contract revenue line.
Of the $55 million to $60 million of expected Captisol sales, Ligand expects approximately $17 million to $19 million to be attributable to core Captisol sales, and the balance to be attributable to treatments for COVID-19. Excluding OmniAb revenue and COVID-related Captisol sales, Ligand expects revenue to be $97 million to $104 million and adjusted earnings per diluted share to be $1.80 to $2.05. Ligand expects the contribution from COVID-related Captisol and the OmniAb business to be between $0.60 and $0.95 per diluted share, resulting in a combined company adjusted earnings per diluted share of $2.40 to $3.00.
Update on the OmniAb Separation Process
On March 23, 2022, Ligand announced the signing of a definitive merger agreement with Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA), a publicly traded special purpose acquisition company (SPAC), providing for the spin-off and merger of OmniAb. The combination of OmniAb and APAC is structured to provide a minimum of $130 million in gross cash to the combined company at the time of closing, and up to $266 million in the event of no redemptions by APAC shareholders.
OmniAb will have an initial pre-money equity valuation of $850 million. Ligand intends to distribute 100% of its ownership in OmniAb to Ligand shareholders immediately prior to the business combination with APAC. The transaction is expected to be tax-free to Ligand and its shareholders for U.S. federal income tax purposes. The transaction is expected to close in the fourth quarter of 2022.
See “Important Information and Where to Find It” and “Participants in the Solicitation” below for additional information regarding the transaction.
Second 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 IntelligenceTM (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. As of June 30, 2022, over 60 partners have access to OmniAb-derived antibodies and more than 270 programs are being actively pursued or commercialized by our partners. As of June 30, 2022, the platform has generated 25 clinical- or commercial- stage OmniAb-derived antibodies.
CStone and Pfizer announced China’s NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy. Sugemalimab, an OmniAb derived monoclonal antibody, became the first anti-PD-1/PD-L1 monoclonal antibody approved for stage III NSCLC following concurrent or sequential chemoradiotherapy. It's also the only anti-PD-L1 monoclonal antibody approved for both stage III and stage IV NSCLC. In May, CStone announced the pre-planned, final progression-free survival (PFS) analysis results from the registrational GEMSTONE-301 study of sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC. The data showed that sugemalimab maintained a statistically significant and clinically meaningful improvement in PFS. Furthermore, on August 7 EQRx, which holds the development and commercialization rights to sugemalimab outside Greater China, announced that the updated, PFS analysis of the Phase 3 GEMSTONE-301 trial showed that sugemalimab continued to demonstrate improvement in PFS compared with placebo. This updated final data was presented in a late-breaking oral presentation at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer, taking place August 6-9, 2022.
Janssen announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended conditional marketing authorization for TECVAYLI® (teclistamab) as monotherapy for adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies. Teclistamab is an OmniAb-derived T-cell redirecting bispecific antibody. It targets both B-cell maturation antigen (BCMA), a marker found on multiple myeloma cells, and CD3, on T-cells. Teclistamab is currently under review by the FDA for potential approval in the U.S.
Immunovant announced recruitment of patients has begun in the pivotal Phase 3 clinical trial of OmniAb-derived batoclimab in myasthenia gravis. Immunovant also announced that it has achieved alignment with the U.S. FDA on plans to initiate two placebo-controlled Phase 3 trials to evaluate batoclimab in thyroid eye disease in the second half of 2022.
Merck KGaA announced the initiation of a Phase 2 trial for M6223, an OmniAb-derived monoclonal antibody targeting TIGIT, in urothelial cancer. The study will evaluate BAVENCIO® (avelumab), a human anti-programmed death ligand-1 (PD-L1) antibody, as monotherapy versus the combination with M6223 or other molecules in the first-line maintenance setting in patients with advanced urothelial carcinoma whose disease did not progress with first-line platinum-containing chemotherapy.
In the second quarter of 2022, OmniAb entered into new platform licensing agreements with LifeArc, BioSynapse, Kaigene, and ReCerise.
Other Portfolio Updates
Travere Therapeutics announced that the FDA accepted and granted priority review of its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2022. Travere provided a regulatory update prior to their second quarter earnings call where they announced plans to submit a Conditional Marketing Authorization application with its partner Vifor Pharma for the treatment of IgA nephropathy in Europe with a review decision expected in the second half of 2023. Travere now plans to pursue traditional approval of sparsentan for focal segmental glomerulosclerosis (FSGS) in 2023 pending completion of the Phase 3 DUPLEX study.
Merck announced FDA approval of VAXNEUVANCE™ for infants and children 6 weeks through 17 years of age. Subsequently, the CDC’s ACIP voted unanimously to provisionally recommend use of VAXNEUVANCE as an option for pneumococcal vaccination in infants and children. VAXNEUVANCE is a 15-valent pneumococcal vaccine utilizing Ligand’s CRM197 vaccine carrier protein produced using the Pelican Expression Technology platform. Additionally, Merck announced positive results from a Phase 1/2 study evaluating V116, their investigational 21-valent pneumococcal conjugate vaccine utilizing Ligand’s CRM197 vaccine carrier protein. Merck started a broad Phase 3 program for V116 in July 2022.
Jazz Pharmaceuticals presented positive data from a Phase 2/3 trial evaluating the intramuscular (IM) administration of Rylaze® in adult and pediatric patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to an E. coli-derived asparaginase at the 2022 ASCO Annual Meeting. The results highlighted that patients achieved clinically meaningful nadir serum asparaginase activity with Rylaze administered on a Monday/Wednesday/Friday schedule. Additionally, Jazz announced the submission an MAA for the potential approval of Rylaze in Europe.
Novan announced positive results from the B-SIMPLE4 pivotal Phase 3 study of SB206 in patients with molluscum contagiosum. At the end of 12 weeks, 32.4% of patients in the SB206 group achieved complete clearance of lesions, as compared with 19.7% of patients in the vehicle group.
Sermonix Pharmaceuticals presented updated data at the 2022 ASCO Annual Meeting from the ELAINE-2 open-label, Phase 2 clinical trial of lasofoxifene in combination with abemaciclib in women with locally advanced or metastatic ER+/HER2 breast cancer and an ESR1 mutation after progression on prior therapies. The combination produced encouraging results, with a median PFS of 13.9 months, along with acceptable tolerability.
Verona Pharma announced it completed patient enrollment with more than 800 subjects randomized in the ENHANCE-1 trial of ensifentrine in chronic obstructive pulmonary disease, concluding enrollment in the Phase 3 ENHANCE program. Top-line data are expected from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around year-end 2022.
Aldeyra Therapeutics announced achievement of the primary endpoint in the Phase 3 TRANQUILITY-2 trial of reproxalap for the treatment of dry eye disease. Reproxalap was statistically superior for both primary endpoints of Schirmer Test (p=0.0001) and ≥10 mm Schirmer Test responder proportions (p<0.0001). Aldeyra subsequently announced achievement of the primary endpoints in a crossover trial showing reproxalap was statistical superior to vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber (p=0.0004) and Schirmer test (p=0.0005). A Type B Pre-NDA meeting is expected to be held with the FDA in 3Q 2022, followed by a potential NDA submission.
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 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 (866) 374-5140 from the U.S. or (808) 238-9813 from outside the U.S. and use conference PIN 84255874#. To participate via live or replay webcast, a link is available at www.ligand.com.
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 the 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 phenotypic screening and mining of next-generation sequencing datasets with custom algorithms 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 in emerging target classes. OmniAb antibodies have been leveraged across modalities, including bispecific antibodies, antibody-drug conjugates and others. The OmniAb suite of technologies span from BI-powered repertoire generation to cutting edge antibody discovery and optimization offering a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.
About Ligand Pharmaceuticals
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 April 2022, in connection with the Business Combination and the Distribution, OmniAb filed with the SEC a registration statement on Form 10 (the “Form 10”) registering shares of OmniAb Common Stock and APAC filed with the SEC a registration statement on Form S-4 (the “Form S-4”) registering shares of APAC Common Stock, warrants and certain equity awards. The Form S-4 filed by APAC includes a proxy statement/prospectus in connection with the APAC shareholder vote required in connection with the Business Combination. The Form 10 filed by OmniAb included portions of the Form S-4 filed by APAC, which will serve as an information statement/prospectus in connection with the spin-off of OmniAb. In June 2022, OmniAb filed with the SEC a request to withdraw the Form 10 because APAC was in the process of responding to comments made by the staff of the Division of Corporation Finance (the “Staff”) with respect to the Form S-4. In the absence of this withdrawal request, pursuant to Section 12(g)(1) of the Securities Exchange Act of 1934, as amended, the Form 10 would have automatically become effective on June 27, 2022. Subsequently, the Staff issued additional comments on APAC’s Form S-4. OmniAb intends to file a replacement registration statement on Form 10 with the SEC in connection with a future pre-effective amendment to the Form S-4 by APAC. This communication does not contain all the information that should be considered concerning the Business Combination. This communication is not a substitute for the registration statements that OmniAb and APAC filed or will file with the SEC or any other documents that APAC or OmniAb may file with the SEC, or that APAC, Ligand or OmniAb may send to stockholders in connection with the Business Combination. It is not intended to form the basis of any investment decision or any other decision in respect to the Business Combination. APAC’s shareholders, Ligand’s stockholders and other interested persons are advised to read the preliminary and, when available, the definitive registration statements, and documents incorporated by reference therein, as these materials will contain important information about APAC, OmniAb and the Business Combination. The proxy statement/prospectus contained in APAC’s Form S-4 will be mailed to APAC’s shareholders as of a record date to be established for voting on the Business Combination.
The registration statements, proxy statement/prospectus/information statement and other documents (when available) are also available free of charge at the SEC’s website at www.sec.gov or by directing a request to: Avista Public Acquisition Corp. II, 65 East 55th Street, 18th Floor, New York, NY 10022.
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 SEC, be deemed participants in the solicitation of APAC’s shareholders in connection with the Business Combination is set forth in the registration statement filed with the SEC. Information about APAC’s executive officers and directors and OmniAb’s management and directors also is set forth in the preliminary registration statements relating to the Business Combination.
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Link: https://ih.advfn.com/stock-market/NASDAQ/ligand-pharmaceuticals-LGND/stock-news/88784859/ligand-reports-second-quarter-2022-financial-resul
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