On May 8, 2018 TESARO, Inc., an oncology-focused biopharmaceutical company, reported results from a TESARO-sponsored Europe-wide literature review examining the views of both patients and physicians on the communication and treatment needs in the care of women with ovarian cancer (Press release, TESARO, MAY 8, 2018, View Source [SID1234526246]). The comprehensive review confirms that the psychosocial effects of ovarian cancer play a significant part in a woman’s quality of life. The review, ‘Our Way Forward – Ovarian Cancer in Europe’ draws data from approximately 65 publications and patient surveys, spanning the last 15 years.

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The ‘Our Way Forward – Ovarian Cancer in Europe’ literature review is part of TESARO’s commitment to ovarian cancer as exemplified by the Our Way Forward program, an initiative that was launched in the U.S. last year. The review is the first step towards supporting the development of patient-focused information tools and bringing the debate in ovarian cancer higher up the medical and political agenda. The review was conducted with guidance and input from European and global patient advocacy organizations, with support by TESARO, under its Our Way Forwardprogram. Our Way Forward was created by TESARO, Inc. with input from the National Ovarian Cancer Coalition (NOCC) and the Ovarian Cancer Research Fund Alliance (OCRFA). The program was launched in June of 2017 and is a call-to-action for ovarian cancer patients, their loved ones and healthcare providers to rethink how they talk about advanced ovarian cancer and ways to partner together to navigate the physical and emotional challenges that the disease brings.

Orlando Oliveira, Senior Vice President and General Manager, TESARO International, explains "TESARO is committed to offering resources to educate, empower and support those affected by ovarian cancer. There is clearly a need for better information and enhanced dialogue around the care of women with ovarian cancer in Europe, as well as new treatments that don’t impair quality of life. Through Our Way Forward and strong collaboration with the patient advocacy community, we aim to help support women with ovarian cancer to speak out and bring their needs to the attention of those that can make a difference, so both their psychological and physical needs can be met, every step of the way."

According to the findings from the literature review, ovarian cancer is frequently diagnosed late,3 leading to urgency in treatment and little time for healthcare professionals (HCPs) to consider the psychological aspects of care.4 The psychological impact of cancer can have a significant impact on treatment outcomes as 80% of women experienced poor mental health2 and patients with depression and anxiety are at a significantly greater risk of mortality, hospitalization and poorer treatment outcomes.5

Despite this, women feel they receive information about the tangible and practical aspects of treatment, but much less so for the psychosocial aspects of the disease and how to cope.4 Women are also less likely to bring the topic up with their HCPs as most women feel uncomfortable raising psychological and emotional concerns during their appointment as they are concerned about taking up too much time.1 As a result, women with ovarian cancer feel isolated, with little support, and feel the need for more information.4

Elisabeth Baugh, Chair, World Ovarian Cancer Coalition, explains that "As the leading global ovarian cancer patient advocacy organization, the World Ovarian Cancer Coalition is pleased to support the release today of this important research undertaken as part of TESARO’s Our Way Forward program. The focus of this work on improving both physical and psychological outcomes for women with ovarian cancer, in Europe and around the world is welcomed, especially as it complements our own World Ovarian Cancer Coalition’s Every Woman Study findings. As we celebrate World Ovarian Cancer Day 2018, the Coalition is pleased to work with all partners on this important day to highlight the struggles that ovarian cancer patients face."

The review also revealed that the ovarian cancer patient journey is fragmented and unpredictable, leading to considerable fear for disease recurrence. Ovarian cancer recurs in approximately 85% of women with advanced ovarian cancer6 and this is at the very top of mind for ovarian cancer survivors. The review also revealed women with recurrent ovarian cancer are not receiving the same level of support as those who are newly diagnosed, with one study showing that for 53% of patients, no one had discussed symptoms of recurrence, and 63% of nurses claim they don’t have the time do so.2

Recurrence of ovarian cancer also takes a psychological toll with 60% of women with recurrence reporting they can do less than they wanted to do because of their emotional status (versus 16% of women without recurrence) and 66% of women with recurrence reporting having trouble concentrating (versus 26% of women without recurrence).7

An important psychological aspect of treatment in relation to allaying fears of recurrence is a discussion around treatment options. Patients need to make a critical trade-off between efficacy and quality of life. This, however, is often under-addressed by their healthcare team. The review revealed that 86% of patients said they would be willing to try a drug that could improve the quality of their life even if it may not prolong it.8

This is the first phase of the ‘Our Way Forward – Ovarian Cancer in Europe’ review, with a second-phase review of the literature planned with healthcare providers to provide a 360-degree picture of the current treatment journey. The full review will offer fresh insights that will support advocacy groups in amplifying the voice of women with ovarian cancer by helping in the development of resources and tools for these women.

On May 8, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics reported financial results for the fiscal quarter ended March 31, 2018 (Press release, Five Prime Therapeutics, MAY 8, 2018, View Source [SID1234526244]).

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"We were pleased that, during the quarter, BMS initiated a Phase 2 clinical trial to evaluate cabiralizumab and OPDIVO as a second-line treatment in patients with advanced pancreatic cancer," said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics. "This randomized, open-label trial has an active comparator arm and is being conducted at multiple sites. This quarter was also a period of pipeline expansion and clinical advancements for Five Prime. FPA150, our first-in-class B7-H4 antibody, recently entered clinical development. We also initiated the safety lead-in for the global Phase 1/3 FIGHT trial of bemarituzumab in gastric cancer, our first registrational trial. Beyond expanding our own pipeline, our platform continues to fuel our collaborators’ pipelines. During the quarter, UCB licensed a drug target identified using our discovery platform and BMS began clinical development of a unique TIM-3 antibody identified through our immuno-oncology research collaboration."

First Quarter 2018 Business Highlights and Recent Developments

Clinical Pipeline:

Cabiralizumab (FPA008): An antibody that inhibits CSF1R and has been shown to block the activation and survival of macrophages.

BMS is conducting a randomized Phase 2 clinical trial in patients with locally advanced or metastatic pancreatic cancer.

In January 2018, Bristol-Myers Squibb Company (BMS) initiated a randomized Phase 2 clinical trial (NCT03336216) to evaluate cabiralizumab and OPDIVO with and without chemotherapy compared to chemotherapy alone as a second-line treatment in patients with advanced pancreatic cancer. The Phase 2 trial is expected to enroll approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.

The advancement of the cabiralizumab and OPDIVO combination into Phase 2 development triggered a $25 million milestone payment to Five Prime.

Five Prime and others have previously demonstrated evidence of synergy by combining CSF1R and PD-1 antibodies with chemotherapy in preclinical models of pancreatic cancer.

Treatment is ongoing in Five Prime’s Phase 1a/1b clinical trial of cabiralizumab and OPDIVO (nivolumab).

Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor OPDIVO in advanced solid tumors. The trial has completed enrollment, patients continue to be treated and biopsies are being assessed for a panel of tissue biomarkers for approximately one third of the patients.

Five Prime and BMS enrolled an additional 35 patients with pancreatic cancer in the Phase 1a portion of the trial to assess efficacy, safety and multiple tissue biomarkers measured in pre- and on-treatment biopsy samples.

The abstract titled "Pharmacodynamics (PD) and Genomic Profiling of Pts Treated with cabiralizumab (cabira) + nivolumab (NIVO) Provide Evidence of On-Target Tumor Immune Modulations and Support Future Clinical Applications" was accepted for a poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Monday, June 4.

Ongoing Phase 1/2 clinical trial (NCT02471716) of cabiralizumab in patients with pigmented villonodular synovitis (PVNS).

Five Prime is enrolling a second cohort of up to 30 additional patients in the Phase 2 portion of the trial to evaluate a less frequent dosing schedule to optimize the therapeutic index of cabiralizumab in this chronic disease setting. Data from these additional patients are intended to enable a go/no go decision by the end of 2018 on whether Five Prime will advance cabiralizumab in PVNS into a pivotal trial in 2019.

Five Prime estimates the combined prevalence of diffuse PVNS is approximately 67,500 patients in the U.S., EU5 and Japan.

Bemarituzumab (FPA144): An isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.

In December 2017, Five Prime initiated the Phase 1 portion (NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial.

The Phase 3 portion of the FIGHT trial will evaluate bemarituzumab in combination with the modified FOLFOX6 standard of care chemotherapy regimen (mFOLFOX6) versus placebo plus mFOLFOX6 in approximately 550 patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b.

The Phase 1 safety lead-in portion of the trial is designed to identify a recommended dose of bemarituzumab in combination with mFOLFOX6 to support the initiation of the Phase 3 portion of the trial.

The Phase 3 portion of the trial is expected to begin in the second half of 2018 and will include sites in the U.S., Europe and Asia, including China, South Korea and Japan, where the incidence of gastric cancer is high.

Five Prime is using immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with FGFR2b-overexpressing gastric cancer who would be eligible for the trial. In April, Five Prime and Personal Genome Diagnostics (PGDx) announced a collaboration to develop a plasma-based ctDNA in vitro companion diagnostic to identify patients for the trial.

Five Prime has filed a clinical trial application for bemarituzumab in China and, via its collaboration with Zai Lab, anticipates initiating clinical trial sites in China by the end of 2018.

In April, Five Prime closed the bladder cancer cohort of its Phase 1 clinical trial after evaluating the feasibility and timing of activating additional clinical sites, the rate of patient enrollment in the bladder cancer cohort and the current landscape of potential treatment options for bladder cancer patients.

The abstract titled "FIGHT: A Phase 3 Randomized, Double-Blind, Placebo Controlled Study Evaluating (Bemarituzumab) FPA144 and Modified FOLFOX6 (mFOLFOX6) in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer with a Dose Finding Phase 1 Lead-In" was accepted for a poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3.
FPA150 (anti-B7-H4): An antibody designed for two mechanisms of action – to block an inhibitory T cell checkpoint pathway and to enhance killing of B7-H4 overexpressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian, endometrial and bladder cancers.

In March, Five Prime initiated patient dosing in a Phase 1a/1b clinical trial of FPA150 monotherapy with a dose-escalation phase in solid tumors, which will be

followed by dose expansion in pre-specified cohorts of patients whose tumors have high B7-H4 expression levels, as measured by an IHC molecular diagnostic test. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and bladder cancers. Phase 1a dose escalation endpoints include identification of a maximum tolerated dose (MTD), safety, and pharmacokinetics (PK) of FPA150. Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

In an oral presentation at the AACR (Free AACR Whitepaper) 2018 Annual Meeting in April, Five Prime presented data showing dose-dependent anti-tumor activity of FPA150 in vivo as a monotherapy and complete tumor regressions in preclinical tumor models when given in combination with PD-1 blockade.
BMS TIM-3 Antibody: Five Prime received a $5 million milestone payment for the first IND filing by BMS for a therapeutic candidate under the immuno-oncology research collaboration between the parties.

In December 2017, BMS filed an IND for the first clinical candidate from the immuno-oncology research collaboration with Five Prime. The candidate is a fully-human monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T-cell responses.

During the quarter, BMS initiated dosing of patients in a Phase 1 study.
Preclinical Research and Development:

FPT155 (CD80-Fc): A CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment and (ii) directly engage CD28 to further enhance its co-stimulatory T-cell activation activity without inducing super agonism.

Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy antitumor activity and may have a synergistic effect when combined with anti-PD1 therapy.

Five Prime anticipates submitting an IND application or a foreign equivalent in the second half of 2018.
Corporate:

In January, the Company completed a public offering of common stock, raising net proceeds of approximately $108 million.

In February, Five Prime received $4.2 million from Zai Lab in connection with the license and collaboration agreement for bemarituzumab in Greater China.

In March, Five Prime received a $25 million milestone payment from BMS for the initiation of the Phase 2 clinical trial evaluating cabiralizumab and OPDIVO (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer.

In March, UCB elected to exclusively license an undisclosed drug target for inflammatory diseases. Five Prime identified the target using its discovery platform.

In March, the Company announced that Marc Belsky, Senior Vice President and Chief Financial Officer, had resigned to pursue another opportunity. Linda Rubinstein has been appointed interim CFO. A search is currently underway to identify a new permanent CFO.
Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $389.4 million as of March 31, 2018, compared to $292.7 million as of December 31, 2017. The increase in cash, cash equivalents and marketable securities was primarily attributable to $107.6 million in net proceeds from the January 2018 public offering of common stock and $25.0 million in milestone payments Five Prime received from collaboration partners net of cash used by Five Prime in operations to advance its three clinical stage programs as well as preclinical research and development.

Revenue. Collaboration and license revenue for the first quarter of 2018 increased by $22.4 million, or 222%, to $32.5 million from $10.1 million for the first quarter of 2017. This increase was primarily related to the $25.0 million earned in the first quarter of 2018 for the milestone achieved under the cabiralizumab collaboration agreement with BMS for the initiation of the Phase 2 clinical trial of cabiralizumab in pancreatic cancer.

R&D Expenses. Research and development expenses for the first quarter of 2018 increased by $9.8 million, or 29%, to $43.6 million from $33.8 million in the first quarter of 2017. This increase was primarily related to increased spending on the bemarituzumab program, including in connection with the initiation of the Phase 1 portion of the FIGHT trial, and the initiation of the FPA150 Phase 1 trial.

G&A Expenses. General and administrative expenses for both the first quarter of 2018 and 2017 were $10.5 million.

Net Loss. Net loss for the first quarter of 2018 was $20.4 million, or $0.63 per basic and diluted share, compared to a net loss of $33.4 million, or $1.21 per basic and diluted share, for the first quarter of 2017.

Shares Outstanding. Total shares outstanding were 34.3 million as of March 31, 2018.
Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than $135 million, which includes the previously mentioned milestone payments earned by Five Prime. Five Prime estimates ending 2018 with approximately $250 million in cash, cash equivalents and marketable securities.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 6585139. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On May 8, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported first quarter 2018 financial results and provided a corporate update (Press release, OncoMed, MAY 8, 2018, View Source [SID1234526243]). As of March 31, 2018, cash, cash equivalents, and short-term investments totaled $88.4 million.

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"The Company is encouraged by ongoing clinical progress on its two most advanced immuno-oncology programs, anti-TIGIT and GITRL-Fc, and preclinical data on these programs were recently highlighted in multiple poster presentations at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We also continue to dose patients in two Phase 1b studies of navicixizumab, our anti-DLL4/VEGF bispecific antibody. We look forward to delivering on numerous near-term catalysts, including the initiation of the Phase 1b portion of the anti-TIGIT study in combination with anti-PD1 in the second quarter of this year, the publication of the navicixizumab Phase 1a manuscript and the presentation of the navicixizumab Phase 1b ovarian cancer data in the second half of 2018, and the planned presentation of the anti-TIGIT Phase 1a data in the fourth quarter of 2018," stated John Lewicki, Ph.D., President and CEO of OncoMed.

Pipeline Highlights

Anti-TIGIT (OMP-313M32)

OncoMed plans to initiate dosing of the Phase 1b portion of its Phase 1a/b anti-TIGIT (OMP-313M32) trial, in combination with anti-PD1, in the second quarter of 2018. The Phase 1b portion of the open-label clinical trial is designed to assess the safety, tolerability, preliminary efficacy, and pharmacodynamic biomarkers of escalating doses of OMP-313M32 in combination with anti-PD1 for the treatment of patients with solid tumors who have progressed after prior treatment with anti-PD1 or anti-PD-L1.
OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses of anti-TIGIT. Biomarkers will be assessed in this study which includes a single-agent dose expansion cohort.
The company currently expects to present data from the Phase 1a portion of the Phase 1a/b study in the fourth quarter of 2018.
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.
To date, OncoMed has enrolled approximately 100 patients across the Phase 1a and Phase 1b trials of navicixizumab.
The Phase 1a data are expected to be published in the second half of 2018, and interim data from the ongoing Phase 1b ovarian cancer study are also expected to be reported in the second half of 2018.
GITRL-Fc (OMP-336B11)

Robust enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.
The Phase 1a data are expected to be presented in 2019.
New product discovery

OncoMed continues to make strong progress in its pursuit of novel immune-oncology agents, including emerging opportunities from the TNF superfamily of ligands, using the company’s proprietary linkerless fully human trimer technology.
First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $88.4 million as of March 31, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $7.8 million for the first quarter of 2018, an increase of $1.6 million, compared to $6.2 million for the same period in 2017. The change in revenue was due to the effect of the adoption of the new revenue recognition standard in the first quarter of 2018. For further discussion regarding our adoption of the new revenue recognition standard and its effects, see page 12 of our Quarterly Report on Form 10-Q for the first quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 8, 2018.

Research and development (R&D) expenses were $8.4 million for the first quarter of 2018, a decrease of $15.6 million, compared to $24.0 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and reduced headcount following the restructuring actions in April 2017.

General and administrative (G&A) expenses were $5.4 million for the first quarter of 2018, an increase of $0.4 million, compared to $5.0 million for the same period in 2017. The increase in G&A expenses was primarily due to an increase in personnel cost, including retention bonus and severance expenses in the first quarter of 2018, offset by a decrease in headcount as a result of restructuring actions in April 2017.

Net loss for the first quarter of 2018 was $5.6 million ($0.15 per share), compared to $22.6 million ($0.61 per share) for the same period of 2017. The change in year-over-year net loss was primarily due to lower operating expenses in the first quarter of 2018.

2018 Financial Guidance

OncoMed’s current cash is estimated to be sufficient to fund operations through at least the third quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be approximately $55 million, before considering potential milestone or opt-in payments.

On May 8, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three months ended March 31, 2018, and provided an operating forecast and program updates (Press release, Ligand, MAY 8, 2018, View Source [SID1234526242]). 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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"Our financial and business results for the first quarter were excellent, highlighted by significant progress with several of our leading partnered assets. Melinta Therapeutics launched newly-approved intravenous Baxdela in the U.S. and their partners made regulatory filings in new geographies. Sage Therapeutics filed a new drug application for intravenous brexanolone for the treatment of postpartum depression and Retrophin initiated a Phase 3 trial with sparsentan for treating focal segmental glomerulosclerosis. We also out-licensed our GRA program, previously our main internal development program, and initiated a new R&D program to address unmet needs in the diagnostic imaging market," said John Higgins, Chief Executive Officer of Ligand. "Ligand’s Shots-on-Goal business model, with its focus on diversification and expense minimization, is continuing to generate increasing cash flow, and we expect this momentum to build throughout the remainder of 2018."

First Quarter 2018 Financial Results

Total revenues for the first quarter of 2018 were $56.2 million, compared with $29.3 million for the same period in 2017. Royalties were $20.8 million, compared with $24.2 million for the first quarter of 2017 and $14.2 million for the second quarter of 2017. Under the new accounting standard ASC 606, adopted as of the start of 2018, first quarter 2018 royalties should be compared with second quarter 2017 royalties due to the timing of revenue recognition. First quarter 2018 royalties primarily consisted of royalties from Promacta, Kyprolis and EVOMELA. Material sales were $4.4 million, compared with $1.1 million for the same period in 2017 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $30.9 million, compared with $3.9 million for the same period in 2017, primarily due to a $20 million upfront payment received upon the licensing of Ligand’s GRA program and other milestones received.

Cost of goods sold was $0.8 million for the first quarter of 2018, compared with $0.3 million for the same period in 2017. Amortization of intangibles was $3.3 million, compared with $2.7 million for the same period in 2017. Research and development expense was $7.4 million, compared with $8.7 million for the same period of 2017 due primarily to lower spending on the GRA program partnered in the first quarter 2018. General and administrative expense was $7.6 million, compared with $7.3 million for the same period in 2017.

GAAP net income for the first quarter of 2018 was $45.3 million, or $1.83 per diluted share, compared with $5.1 million, or $0.22 per diluted share for the same period in 2017. First quarter of 2018 included a one-time, non-cash gain due to a change in the accounting for our investment in Viking Therapeutics, which resulted in marking the investment to market. Adjusted net income for the first quarter of 2018 was $35.7 million, or $1.55 per diluted share, compared with adjusted net income of $12.6 million, or $0.57 per diluted share, for the same period in 2017.

As of March 31, 2018, Ligand had cash, cash equivalents and short-term investments of $264.4 million in addition to our $27.5 million investment in Viking Therapeutics. Cash generated from operations was $60.8 million for the first quarter of 2018.

2018 Financial Guidance

Ligand affirms previous guidance for 2018 revenue to be approximately $184 million, including royalties of approximately $116 million, material sales of approximately $23 million and license fees and milestones of approximately $45 million, with the potential for up to an additional $20 million in license fees and milestones. Ligand notes that with revenue of $184 million, adjusted earnings per diluted share would be approximately $4.85.

First Quarter 2018 and Recent Business Highlights

Promacta/Revolade

Novartis reported first quarter 2018 net sales of Promacta/Revolade (eltrombopag) of $257 million, an $82 million or 47% increase over the same period in 2017.

Novartis announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Promacta for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia as a first-line therapy.

Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On April 24, 2018, Amgen reported first quarter net sales of Kyprolis of $222 million, a $32 million or 17% increase over the same period in 2017. On May 9, 2018, Ono Pharmaceutical Company is expected to report Kyprolis sales in Japan for the most recent quarter.

On January 17, 2018, Amgen announced that the FDA approved the supplemental New Drug Application to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for Kyprolis.

On January 30, 2018, Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) adopted a positive opinion recommending a label variation for Kyprolis to include updated OS data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma.

On April 30, 2018, Amgen announced that the CHMP adopted a positive opinion recommending a label variation for Kyprolis to include the final overall survival (OS) data from the Phase 3 ASPIRE trial.

New Licensing Deals

Ligand announced the signing of a license agreement granting Roivant Sciences exclusive global rights to develop and commercialize LGD-6972 (now named RVT-1502), Ligand’s glucagon receptor antagonist (GRA). Under the terms of the agreement, Ligand received a $20 million upfront license fee, and is eligible to receive up to an additional $528.8 million of milestone payments and tiered royalties ranging from low double digits to the mid-teens, with the top tier applying to annual net sales above $3 billion. Roivant is responsible for all costs related to the program.

Ligand announced worldwide license agreements with venBio Partners, Ferring Pharmaceuticals and Glenmark Pharmaceuticals to use the OmniAb platform technologies to discover fully human antibodies. The agreement with venBio permits the venture capital firm’s portfolio companies to enter into worldwide OmniAb

platform agreements under previously agreed-upon terms. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.

Additional Pipeline and Partner Developments

Sage Therapeutics announced the submission of a New Drug Application to the FDA for an intravenous (IV) formulation of brexanolone for the treatment of postpartum depression.

Retrophin announced first patient enrollment in the Phase 3 DUPLEX Study evaluating the long-term nephroprotective potential of sparsentan for the treatment of focal segmental glomerulosclerosis. Topline data from the 36-week interim efficacy endpoint analysis are expected in the second half of 2020.

Retrophin announced that the company received regulatory feedback from both the FDA and European Medicines Agency (EMA) on the development pathway for sparsentan in IgA nephropathy and that a single registration-enabling Phase 3 clinical trial is expected to be initiated in the fourth quarter of 2018

Melinta Therapeutics announced the U.S. launch of the Captisol-enabled IV formulation of Baxdela for the treatment of adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.

Melinta Therapeutics announced that The Menarini Group and Eurofarma Laboratórios submitted regulatory applications for delafloxacin (Baxdela in the U.S.) in the European Union and Argentina, respectively.

CASI Pharmaceuticals announced a $50 million private placement to prepare for commercialization in China, including potentially for EVOMELA, which has a regulatory application outstanding under priority review with an Expert Advisory Committee review date of April 25-26, 2018.

Aldeyra Therapeutics announced enrollment of the first patient in a Phase 3 clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis and also enrollment of the first patient in a Phase 2b clinical trial of reproxalap for the treatment of dry eye disease.

Aldeyra Therapeutics presented the results of a Phase 2a dry eye disease clinical trial of topical ocular reproxalap at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting.

Exelixis announced that its partner Daiichi Sankyo had submitted a regulatory application for esaxerenone (CS-3150) in patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency.

Takeda Pharmaceuticals highlighted the Phase 3 initiation of pevonedistat and its TAK-020 program during its presentation at the JP Morgan 36th Annual Healthcare Conference.

Merrimack Pharmaceuticals announced it had dosed the first patient in its Phase 2 SHERBOC study of MM-121 (seribantumab) in patients with heregulin-positive, hormone receptor-positive and HER2-negative post-menopausal metastatic breast cancer.

Viking Therapeutics announced the pricing of a $63.3 million public offering of common stock (including over-allotment exercise) with proceeds to fund continued development of VK5211, VK2809 and VK0214.

Opthea announced commencing a Phase 1b/2a trial evaluating the safety and efficacy of OPT-302 in patients with center-involved diabetic macular edema.

Syros Pharmaceuticals announced new preclinical data showing that Captisol-enabled SY-1365, a first-in-class selective cyclin-dependent kinase 7 inhibitor currently in a Phase 1 trial in patients with advanced solid tumors, demonstrated potent anti-tumor activity in multiple models of heavily pretreated ovarian cancer.

Aptevo Therapeutics announced that it had submitted an Investigational New Drug application to the FDA to evaluate APVO436 in a Phase 1 clinical study for the treatment of patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Aptevo Therapeutics presented new data for APVO436 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting.

OmniAb partner Ferring Pharmaceuticals announced it is expanding its capabilities in biologics by constructing a new CHF30 million biotech center and manufacturing site.

Arcus Biosciences presented a poster on OmniAb-derived GLS-010 (AB122) at the AACR (Free AACR Whitepaper) 2018 Annual Meeting.

Nucorion Pharmaceuticals presented preclinical data for its novel liver-targeting prodrug technology program, NCO-1010, for the potential treatment of hepatitis B at the European Association for the Study of the Liver’s International Liver Congress.

Internal Research and Development

Ligand announced initiation of an internally funded program to develop through proof-of-concept contrast agents with reduced renal toxicity for diagnostic imaging procedures. This development program will leverage Ligand’s Captisol technology, as well as intellectual property obtained through its acquisition of Verrow Pharmaceuticals for $2 million in cash plus earn outs.

Ligand presented a poster at the National Lipid Association’s 2018 Scientific Sessions showing that Ligand’s LTP Technology significantly improves liver targeting of the statin rosuvastatin (Crestor), and may potentially be an effective strategy to increase the therapeutic index of statins and reduce statin intolerance.

A paper by Ligand scientists entitled "Chickens with humanized immunoglobulin genes generate antibodies with high affinity and broad epitope coverage to conserved targets" was published in the journal MAbs, highlighting the use of OmniChicken in antibody drug discovery.

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, net losses of Viking Therapeutics, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, unissued shares relating to the Senior Convertible Notes 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 revenue, the Company only provides 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, net losses of Viking Therapeutics, stock-based compensation expense, mark-to-market adjustments for amounts owed to licensors, effects of any discrete income tax items and fair value adjustments to Viking Therapeutics convertible note receivable. 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 2259939. To participate via live or replay webcast, a link is available at www.ligand.com.

On May 8, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 10:40 a.m. PDT on Wednesday, May 16, at the Bank of America Merrill Lynch Health Care Conference 2018 (Press release, Puma Biotechnology, MAY 8, 2018, View Source [SID1234526241]). The conference will be held at Encore at the Wynn in Las Vegas.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com . The presentation will be archived on the website and available for 30 days.

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