On May 2, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that it will release first quarter 2019 financial results after the market closes on Thursday, May 9, 2019 (Press release, Xencor, MAY 2, 2019, View Source [SID1234535551]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 8597541. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 90 days.

On May 2, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the three months ended March 31, 2019 (Press release, Emergent BioSolutions, MAY 2, 2019, View Source [SID1234535550]).

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Q1 2019 AND RECENT BUSINESS ACCOMPLISHMENTS

Procurement Contract

Signed a contract with the U.S. Department of State valued at up to $100 million over 10 years to establish a long-term, reliable supply chain of medical countermeasures for chemical threats, including the supply of RSDL (Reactive Skin Decontamination Lotion Kit) and Trobigard atropine sulfate/obidoxime chloride auto-injector.

Product Development

Initiated a Phase III trial to evaluate the lot consistency, immunogenicity and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant), with funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) pursuant to a development and procurement contract signed in September 2016; the Company also initiated manufacturing of AV7909 in Q1 2019.

Provided interim analysis of the Phase II clinical study evaluating the safety and immunogenicity of the Company’s chikungunya virus virus-like-particle vaccine candidate, CHIKV-VLP, showing with a single dose administered up to 98% of study participants produced neutralizing antibodies against the chikungunya virus by day 7, with persistent effect out to the six-month visit, including in the single-dose regimen.

2019 FINANCIAL PERFORMANCE

Revenues

Total Revenues
For Q1 2019, total revenues were $190.6 million, an increase of 62% over 2018. Total revenues reflect a significant increase in product sales due to the contribution of recently acquired products.

Product Sales
For Q1 2019, product sales were $153.0 million, an increase of $77.2 million or 102% as compared to 2018. The increase primarily reflects sales of NARCAN (naloxone HCl) Nasal Spray, which was acquired in October 2018, and ACAM2000 (Smallpox (Vaccinia) Vaccine, Live).

Contract Manufacturing
For Q1 2019, revenue from the Company’s contract manufacturing operations was $15.9 million, a decrease of $10.2 million or 39% as compared to 2018. The decrease primarily reflects contracted service work in Q1 2018 that did not recur in Q1 2019.

Contracts and Grants
For Q1 2019, revenue from the Company’s development-based contracts and grants was $21.7 million, an increase of $5.8 million or 36% as compared to 2018. The increase primarily reflects increased R&D activities related to certain ongoing funded development programs, most notably AV7909.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q1 2019, cost of product sales and contract manufacturing was $91.8 million, an increase of $37.5 million or 69% as compared to 2018. The increase primarily reflects the impact of an increase in product sales due to the contribution of recently acquired products NARCAN Nasal Spray, Vivotif(Typhoid Vaccine Live Oral Ty21a), and Vaxchora (Cholera Vaccine, Live, Oral), which were all acquired in October 2018, as well as the contribution of increased ACAM2000 sales.

Research and Development (Gross and Net)
For Q1 2019, gross R&D expenses were $46.1 million, an increase of $17.0 million or 58% as compared to 2018. The increase primarily reflects costs associated with incremental development programs from the recent acquisitions of PaxVax and Adapt Pharma in October 2018, as well as timing of manufacturing development activities related to the AV7909 program.

For Q1 2019, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $24.4 million, an increase of $11.2 million or 85% as compared to 2018. The increase primarily reflects investments in the development of the CHIKV-VLP vaccine, FLU-IGIV hyperimmune and various programs related to opioid overdose response, which are part of the development portfolio resulting from the Adapt Pharma acquisition in October 2018. The Q1 2019 net R&D expense was 14% of net revenue (total revenue less contracts & grants) compared to 13% of net revenue in Q1 2018.

Selling, General and Administrative
For Q1 2019, selling, general and administrative expenses were $65.4 million, an increase of $25.4 million or 64% as compared to 2018. The increase primarily reflects the addition of the operations associated with the October 2018 acquisitions of both PaxVax and Adapt Pharma.

Amortization of Intangible Assets
For Q1 2019, amortization of intangible assets was $14.5 million versus $3.9 million as compared to 2018. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions, which both closed in October 2018.

Income Taxes
For Q1 2019, the benefit from income taxes in the amount of $11.8 million includes the impact of non-deductible acquisition transaction costs and other permanent items. The effective tax rate for Q1 2019 is not meaningful given the lack of any pre-tax income for the quarter.

Net Income (Loss) & Adjusted Net Income (Loss)
For Q1 2019, the Company recorded a net loss of $26.0 million, or $0.51 per diluted share, versus a net loss of $4.9 million, or $0.10 per diluted share, in 2018.

For Q1 2019, the Company recorded an adjusted net loss of $6.8 million, or $0.13 per diluted share, versus an adjusted net loss of $1.6 million, or $0.03 per diluted share, in 2018.

EBITDA & Adjusted EBITDA
For Q1 2019, the Company recorded EBITDA of $(1.6) million versus $3.1 million in 2018.

For Q1 2019, the Company recorded adjusted EBITDA of $7.4 million versus $3.3 million in 2018. (1)

2019 FINANCIAL FORECAST (Reaffirmed)

For full year 2019, the company reaffirms its expectation of the following forecasted financial metrics:

The Company’s financial forecast for 2019 includes the anticipated impact of full year product sales, continued contract manufacturing and contracts & grants revenue as well as continued investment in discretionary funding development projects. The outlook for 2019 does not include estimates for potential new corporate development or other M&A transactions.

Q2 2019 REVENUE FORECAST

For Q2 2019, the Company forecast for total revenues is $200 million to $220 million.

FOOTNOTES

(1) See "Reconciliation of Net Income (Loss) to Adjusted Net Income (Loss), EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation table.

CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, May 2, 2019, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent’s website:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 8099738

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."

On May 2, 2019 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the first quarter ended March 31, 2019 (Press release, CTI BioPharma, MAY 2, 2019, View Source [SID1234535548]).

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"Advancing our U.S. and European development program for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia remains our top priority for 2019, and we anticipate multiple important milestone events for pacritinib this year," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We are currently preparing to meet with the U.S. Food and Drug Administration (FDA) and report the determination of an optimal dose of pacritinib in mid-2019, and we expect to begin enrolling a Phase 3 registration study of pacritinib soon after. We also anticipate announcing top-line safety and efficacy data from the Phase 2 study of pacritinib and are targeting presentation of the results at a scientific conference before the end of the year."

Expected 2019 Milestones

FDA meeting and determination of the optimal dose of pacritinib – mid-2019

Commence enrollment in Phase 3 study of pacritinib in myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter) – Q3 2019

Reporting of top-line efficacy and safety data from PAC203 Phase 2 study at a major medical meeting by the end of 2019

First Quarter Financial Results
Total revenues for the three months ended March 31, 2019 were $0.6 million compared to $10.8 million for the same period in 2018. The decrease in total revenues for the first quarter in 2019 compared to the same period in 2018 is primarily due to the recognition of $10.0 million in license and contract revenue in 2018 from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX (arsenic trioxide) for first-line treatment of acute promyelocytic leukemia.

Operating loss was $10.5 million for the first quarter of 2019, compared to operating loss of $4.3 million for the same period in 2018. Operating loss in the first quarter of 2019 as compared to operating loss in the same period in 2018 resulted primarily from the decrease in license and contract revenue as mentioned above.

Net loss attributable to common stockholders for the first quarter of 2019 was $10.8 million, or $(0.19) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $4.1 million, or $(0.08) for basic and diluted loss per share, for the same period in 2018.

As of March 31, 2019, cash, cash equivalents and short-term investments totaled $62.3 million, compared to $67.0 million as of December 31, 2018. CTI BioPharma expects current cash, cash equivalents and short-term investments will enable it to fund operating and capital expenditures through the second quarter of 2020.

On May 2, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported operational highlights and financial results for the first quarter ended March 31, 2019 (Press release, Intellia Therapeutics, MAY 2, 2019, View Source [SID1234535544]). Additionally, the Company highlighted important corporate milestones for 2019.

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"2019 is off to a productive start in support of our mission to advance genome editing to treat a range of severe and life-threatening diseases. We are excited by our achievements in gene knockout and insertion across both our in vivo and engineered cell therapy efforts. In particular, we presented data at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) showing unprecedented CRISPR-mediated, targeted gene insertion in the liver of non-human primates, achieving normal circulating human levels of protein production," said Intellia President and Chief Executive Officer John Leonard, M.D. "These achievements highlight Intellia’s leadership in CRISPR/Cas9 genome editing as we advance our pipeline towards the clinic. Looking ahead, we remain on track to file an IND application next year for NTLA-2001, our lead in vivo candidate for the treatment of transthyretin amyloidosis, and expect to nominate a development candidate in our first engineered cell therapy program for acute myeloid leukemia by year-end."

First Quarter 2019 and More Recent Operational Highlights

ATTR Program: Intellia’s lead candidate for the treatment of transthyretin amyloidosis (ATTR), which demonstrated an average of >95% reduction in circulating transthyretin (TTR) protein in non-human primates (NHPs), has been nominated as the Company’s first in vivo development candidate to advance into Investigational New Drug (IND)-enabling toxicology studies. Preliminary results from substantially completed dose-range finding (DRF) studies showed a favorable tolerability profile; and data from multiple studies in NHPs demonstrated durable liver editing with sustained reduction of circulating TTR through 10 months of observation following a single dose.

Today, Intellia announced plans to begin IND-enabling toxicology studies of NTLA-2001 in mid-2019 and that it remains on track to submit an IND application in 2020. NTLA-2001 is being co-developed with Regeneron Pharmaceuticals, Inc. (Regeneron), with Intellia as the lead development and commercialization party.
AML Program: Intellia and its research collaborators at IRCCS Ospedale San Raffaele presented new in vitro data at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), showing that CRISPR/Cas9 editing resulted in >98% knockout of endogenous T cell receptors (TCRs) followed by insertion of Wilms’ Tumor 1 (WT1)-specific TCRs into >95% of isolated T cells. In addition, the engineered T cells were functional and capable of specifically killing high levels of a panel of leukemic blasts from patients that expressed the WT1 epitope. Based on these results, Intellia has identified multiple lead TCRs restricted to the HLA-A*02:01 allele to move into functional testing in patient-derived xenograft models for an autologous TCR-based therapy targeting WT1 for the treatment of acute myeloid leukemia (AML). These studies are expected to begin in mid-2019 and will inform the nomination of the Company’s first engineered cell therapy development candidate by the end of 2019.

In Vivo Insertion in NHPs: At the 2019 ASGCT (Free ASGCT Whitepaper) Meeting, Intellia presented data demonstrating the first CRISPR-mediated, targeted transgene insertion in the liver of NHPs, using Factor 9 (F9) as a model gene. F9 is a gene that encodes for Factor IX (FIX) protein, a blood-clotting protein that is missing or defective in hemophilia B patients. In a collaboration between Intellia and Regeneron, researchers combined Intellia’s lipid nanoparticle (LNP) delivery system of CRISPR/Cas9 with an adeno-associated virus (AAV) containing a proprietary bi-directional insertion template. NHP data showed that a single administration achieved ~3-4 μg/mL of circulating human FIX protein at day 14 and was sustained through 28 days (~3-5 μg/mL) of completed observation in an ongoing study. The levels of circulating human FIX protein demonstrated in NHPs correspond with the normal 3-5 μg/mL range of human FIX protein levels (source: Amiral et al, Clin. Chem., 1984). The NHP data shared also incorporates the improved CRISPR/Cas9 LNP identified from the ATTR program and demonstrates the modularity of Intellia’s platform to apply learnings to other programs. This data expands on the clinically relevant human FIX protein levels achieved in mice, first reported in October, which have remained stable through 10 months of observation.

Modular In Vivo Knockout Update: Today, at the 2019 ASGCT (Free ASGCT Whitepaper) Meeting, Intellia will present new data demonstrating that independent CRISPR-mediated knockout of each of two targets of interest, either lactate dehydrogenase A (Ldha) or hydroxyacid oxidase 1 (Hao1), via the Company’s proprietary LNP delivery technology, results in a durable, therapeutically relevant reduction of oxalate excretion in a disease mouse model of primary hyperoxaluria type 1 (PH1).

LDHA and HAO1 are enzymes involved in oxalate production. In people with PH1, mutations in a specific liver enzyme cause the production of a surplus of oxalate, which can combine with calcium to form insoluble deposits in the kidney and throughout the body, leading to damage of the kidneys, heart, eyes and skeletal system. An approximate 30% reduction in urinary oxalate in patients with PH1 is considered to be therapeutically relevant (source: Nephrology Dialysis Transplantation 1999; 14:2556-2558). In collaboration with the University of Alabama at Birmingham, Intellia researchers found that a CRISPR-mediated knockout of the Ldha gene in a PH1 mouse model disrupts LDHA protein production and reduces urinary oxalate levels by 63%. Researchers also observed that a CRISPR-mediated knockout of the Hao1 gene disrupts glycolate-to-glyoxylate conversion, resulting in a urinary oxalate level reduction of 57% in a PH1 mouse model. In each individual knockout approach, these reduced levels of urinary oxalate were sustained for at least 15 weeks.

Today’s presentation, titled "CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria," is accessible through the Events and Presentations page of the Investor Relations section of Intellia’s website.
Upcoming Milestones

The Company has set forth the following for 2019 pipeline progression:

ATTR:
Initiate IND-enabling toxicology studies in mid-2019
Commence manufacturing of NTLA-2001 Phase 1 materials
AML:
Initiate functional testing in patient-derived xenograft models of multiple lead TCRs in mid-2019
Nominate first engineered cell therapy development candidate by the end of 2019
First Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $296.6 million as of March 31, 2019, compared to $314.1 million as of December 31, 2018. The decrease was driven by cash used to fund operations of approximately $29 million, which was offset in part by $6.0 million of funding received under the Novartis collaboration, $3.6 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $1.5 million of ATTR cost reimbursements made by Regeneron, and $0.4 million in proceeds from employee-based stock plans.
Collaboration Revenue: Collaboration revenue increased by approximately $3.0 million to $10.4 million during the first quarter of 2019, compared to $7.5 million during the first quarter of 2018. The increase in collaboration revenue in 2019 was primarily driven by amounts recognized from the expansion of the existing collaboration with Novartis, as well as by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron is obligated to fund approximately 50% of the development costs for the ATTR program.
R&D Expenses: Research and development expenses increased by $1.2 million to $23.7 million during the first quarter of 2019, compared to $22.5 million during the first quarter of 2018. This increase was driven primarily by the advancement of Intellia’s research programs, research personnel growth to support these programs, as well as the expansion of the development organization.
G&A Expenses: General and administrative expenses increased by $3.1 million to $10.5 million during the first quarter of 2019, compared to $7.4 million during the first quarter of 2018. This increase was driven primarily by employee and intellectual property (IP)-related expenses to support Intellia’s growing research and development efforts.
Net Loss: The Company’s net loss was $21.9 million for the first quarter of 2019, compared to $21.4 million during the first quarter of 2018.
Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of March 31, 2019, as well as technology access and funding from Novartis and Regeneron, will enable Intellia to fund its anticipated operating expenses and capital expenditure requirements into the first half of 2021. This expectation excludes any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss First Quarter 2019 Earnings

The Company will discuss these results on a conference call today, May 2, 2019, at 8 a.m. ET. The investor presentation may be downloaded starting at 7:30 a.m. ET from the Events and Presentations page of the Investor Relations section of Intellia’s website at intelliatx.com.

To join the call:

U.S. callers should dial 800-458-4148 and use conference ID# 7725705, approximately five minutes before the call.
International callers should click here to access dial-in information and use conference ID# 7725705, approximately five minutes before the call.
A replay of the call will be available on Intellia’s website, beginning on May 2, 2019 at 12 p.m. ET.

On May 2, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three months ended March 31, 2019 and provided an operating forecast and program updates (Press release, Ligand, MAY 2, 2019, View Source [SID1234535543]). Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

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"The first quarter of 2019 was a great start to the year for Ligand. We saw an important new drug approved that will generate royalties for Ligand, we completed six new OmniAb and Captisol licensing deals, invested in a new technology company called Dianomi and saw our first OmniAb partnered program enter Phase 3 testing. This past quarter we divested Promacta for $827 million, converting the remaining years of royalty cash to be generated into capital today that can be reinvested into growing our business. Our partnered programs experienced significant value-enhancing events in the first quarter with a calendar for the rest of the year stacked with several substantial events," said John Higgins, Chief Executive Officer of Ligand. "At our analyst day we laid out our strategic priorities and cash investment agenda, which centers on M&A, project-financing royalty purchases, seed investments into technology companies and share repurchases. We have a highly diversified portfolio and robust financial outlook with attractive growth of top and bottom lines projected and meaningful expansion of our operating margins anticipated."

First Quarter 2019 Financial Results

Total revenues for the first quarter of 2019 were $43.5 million, compared with $56.2 million for the same period in 2018. Royalties were $19.5 million, compared with $20.8 million for the same period in 2018 and primarily consisted of royalties from Promacta, Kyprolis and EVOMELA. Royalties reflect Ligand’s sale of Promacta to Royalty Pharma as of March 6, 2019, resulting in a partial quarter of Promacta royalties, and Ligand will not receive Promacta royalties going forward. Material sales were $9.0 million, compared with $4.4 million for the same period in 2018 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $15.0 million, compared with $30.9 million for the same period in 2018, with the prior-year quarter including an upfront milestone payment upon the out-license of Ligand’s Glucagon Receptor Antagonist program to Roivant Sciences.

Cost of material sales was $3.9 million for the first quarter of 2019, compared with $0.8 million for the same period in 2018. Amortization of intangibles was $3.5 million, compared with $3.3 million for the same period in 2018. Research and development expense was $11.3 million, compared with $7.4 million for the same period of 2018, due to costs associated with recent acquisitions. General and administrative expense was $11.1 million, compared with $7.6 million for the same period in 2018, due to costs associated with recent acquisitions and non-cash stock-based compensation expense.

Net income for the first quarter of 2019 was $666.3 million, or $31.32 per diluted share, compared with net income of $45.3 million, or $1.83 per diluted share, for the same period in 2018. Net income for the first quarter of 2019 was impacted by an after-tax gain of just over $640 million on the sale of Ligand’s assets and royalty on Promacta to Royalty Pharma. Adjusted net income for the first quarter of 2019 was $24.8 million, or $1.16 per diluted share excluding the impact of the gain recognized on the sale of Promacta, compared with adjusted net income of $35.7 million, or $1.55 per diluted share, for the same period in 2018.

As of March 31, 2019, Ligand had cash, cash equivalents and short-term investments of approximately $1.4 billion. Cash generated from operations during the first quarter of 2019 was $45.3 million.

2019 Financial Guidance

Ligand is affirming existing revenue guidance for 2019 with total revenues expected to be approximately $118 million including royalties of approximately $48 million, material sales of approximately $27 million and license fees and milestones of approximately $43 million. Ligand is also affirming its existing adjusted earnings per share guidance of approximately $3.20, which excludes the impact of the gain recognized on the sale of Promacta of $30.09 per share compared to the initial estimate of the impact of the gain of $29.05 per share.

First Quarter 2019 and Recent Business Highlights

Promacta

In March 2019, Ligand announced the sale of Promacta to Royalty Pharma for $827 million in cash. As of March 6, 2019 Ligand will not receive any royalty on sales of Promacta.
Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On April 30, 2019, Amgen reported first quarter 2019 net sales of Kyprolis of $245 million, a $23 million or 10% increase over the same period in 2018.
Recent Acquisitions, Targeted Investments and Partner Funding Events

Ligand announced a $3 million investment in Dianomi Therapeutics in exchange for 1) a tiered royalty of 2% or 3% based on level of net sales for the first five products to be approved using Dianomi’s patented Mineral Coated Microparticle (MCM) technology, and 2) a loan convertible into $1 million of equity at the next qualified financing.
Seelos Therapeutics completed a reverse merger with Apricus Biosciences and is now publicly traded on the Nasdaq Capital Market under the symbol "SEEL". In conjunction with the transaction, Seelos issued common stock and warrants in a private round led by a group of leading venture capital investors, for gross proceeds of $18 million.
CStone Pharmaceuticals listed shares on the Hong Kong Stock Exchange and raised $266 million in an equity offering that, in part, will be used to fund the company’s OmniAb-derived Phase 2/3 program CS1001.
Internal R&D

Ligand announced completion of enrollment of the Company’s Phase 1 clinical trial of its internal Captisol-enabled Iohexol program and announced that top-line data from the trial is expected in the third quarter of 2019.
Additional Pipeline and Partner Developments

Ligand’s portfolio of partnerships now includes more than 200 Shots on Goal driven by business development and licensing activity, and the expansion and advancement of OmniAb partnerships.
Sage Therapeutics announced U.S. Food and Drug Administration (FDA) approval of ZULRESSO (brexanolone) injection for the treatment of postpartum depression. Ligand received a $3 million milestone payment as a result of the approval. Sage Therapeutics plans to launch ZULRESSO in late June 2019.
Daiichi Sankyo announced receipt of marketing approval in Japan for MINNEBRO (esaxerenone) for the treatment of hypertension.
Melinta Therapeutics announced preparation of a supplemental new drug application (sNDA) for Baxdela in community-acquired bacterial pneumonia with the sNDA expected to be filed in the second quarter of 2019.
CStone Pharmaceuticals announced dosing of the first patient in a Phase 3 clinical trial assessing OmniAb-derived CS1001 in combination with chemotherapy for the treatment of gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
Viking Therapeutics announced that additional VK2809 Phase 2 data was presented at the 2019 annual meeting of the European Association for the Study of Liver, and that results demonstrated promising efficacy at doses as low as 5 mg daily. Viking also announced plans to initiate a Phase 2b study of VK2809 in biopsy-confirmed NASH in the second half of 2019.
Metavant updated Ligand that they no longer plan to initiate a clinical proof-of-concept trial this year for RVT-1502 in Type 1 diabetes following requests from FDA for additional non-clinical studies. Metavant is evaluating its development plans for the program, and we expect them to provide an update on the status of the program.
Verona Pharma announced positive interim efficacy and safety data from part one of a two-part Phase 2 clinical trial of a dry powder inhaler formulation of ensifentrine in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Verona Pharma also announced the European Patent Office granted an additional key patent relating to the company’s lead development candidate ensifentrine.
Sermonix Pharmaceuticals announced a poster presentation on the performance of its lead investigational drug, lasofoxifene, at ENDO 2019.
Opthea Limited announced that the independent Data and Safety Monitoring Board for the company’s ongoing Phase 2b study of OPT-302 in wet age-related macular degeneration reaffirmed its positive recommendation that the trial continue without modification.
Aptevo Therapeutics provided an update on OmniAb-derived APVO436 and announced that Phase 1 data is anticipated in the fourth quarter of 2019. New preclinical data for APVO436 was also presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting.
OmniAb partner xCella Biosciences presented high-throughput functional screening of antibody libraries, highlighting OmniRat and OmniChicken, at the 2019 Protein Engineering Summit (PEGS).
Business Development

Ligand announced a worldwide license agreement with Genagon Therapeutics AB to use the OmniAb platform technologies to discover fully human antibodies. Genagon is an immuno-oncology biotechnology company located in Sweden. Ligand is eligible to receive development milestone payments and tiered royalties on future product sales.
Ligand disclosed a worldwide license agreement with a San Francisco Bay Area venture-stage biotechnology company to use the OmniAb platform technologies to discover fully human antibodies. Ligand is eligible to receive development and commercial milestone payments and royalties on future product sales.
Ligand entered into new Captisol clinical use or commercial license and supply agreements with Merck KGaA, reVision Therapeutics, Takeda and SQ Innovation.
Publications and Presentations

At PEGS 2019 Ligand scientists announced the launch of OmniClic, a novel next-generation common light chain OmniChicken-based antibody discovery technology focused on bispecific antibodies.
Preclinical data of the combination of the BCL-2 inhibitor S55746 and the MCL1 inhibitor S63845, compounds originating from the Servier collaboration and now partnered with Novartis, in models of AML were recently published in the journal Leukemia, demonstrating potential to rapidly suppress leukemia with limited toxicity to normal human bone marrow cells compared to chemotherapy.
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 stock-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, unissued shares relating to the Senior Convertible Notes, gain on the sale of Promacta 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 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 (833) 591-4752 from the U.S. or (720) 405-1612 from outside the U.S., using the conference ID 6375579. To participate via live or replay webcast, a link is available at www.ligand.com.