Keryx Biopharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Keryx Biopharmaceuticals, 2018, FEB 21, 2018, View Source [SID1234524111]).

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On February 21, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported its Annual Report for 2017 (Press release, Genmab, FEB 21, 2018, View Source [SID1234524098]). Below is a summary of business progress and financial performance for the year, and financial outlook for 2018 from the report. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com. An online summary of the report is available at View Source

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2017 ACHIEVEMENTS

Business Progress

Maximize daratumumab progress

EMA decision & launch in 2nd line + multiple myeloma (MM) relapsed / refractory setting – Achieved
FDA decision 3rd line MM setting (daratumumab + pomalidomide) – Achieved
Phase III MM interim efficacy analysis in frontline (ALCYONE trial) – Achieved
Start Phase III subcutaneous trial – Achieved
Start trials in solid tumors and non-MM blood cancers – Achieved
Report non-MM clinical data — Expected in 2018
Optimize ofatumumab value

Phase III refractory FL headline results — Expected in 2018
Strengthen differentiated product pipeline

Phase I/II tisotumab vedotin data – Achieved
Progress HuMax-AXL-ADC Phase I/II clinical trial – Achieved
IND/CTA submission HexaBody-DR5/DR5 – Achieved
IND/CTA submission DuoBody-CD3xCD20 – Achieved
Progress pre-clinical pipeline — Achieved
Strengthen partnership portfolio with next generation technologies

Enter new technology collaborations — Not achieved
Progress partnered programs — Achieved
Disciplined financial management

Execute controlled company growth with selective investments in product pipeline — Achieved
Financial Performance

Revenue was DKK 2,365 million in 2017 compared to DKK 1,816 million in 2016. The increase of DKK 549 million, or 30%, was mainly driven by higher DARZALEX royalties under our daratumumab collaboration with Janssen.
Operating expenses increased by DKK 258 million, or 34%, from DKK 763 million in 2016 to DKK 1,021 million in 2017 driven by the advancement of tisotumab vedotin, the addi­tional investment in our product pipeline, and the increase in employees to support the expansion of our pipeline.
Operating income was DKK 1,344 million in 2017 compared to DKK 1,053 million in 2016. The improvement of DKK 291 million, or 28%, was driven by higher revenue, which was partly offset by increased operating expenses.
2017 year end cash position of DKK 5,423 million, an increase of DKK 1,501 million, or 38%, from DKK 3,922 million as of December 31, 2016.
2018 OUTLOOK

MDKK 2018 Guidance 2017 Actual Result
Revenue 2,700 — 3,100 2,365
Operating expenses (1,400) — (1,600) (1,021)
Operating income 1,300 — 1,500 1,344

Revenue
We expect our 2018 revenue to be in the range of DKK 2,700 — 3,100 million, compared to DKK 2,365 million in 2017. Our projected revenue for 2018 consists primarily of DARZALEX royalties of approximately DKK 1,750 million that are based on an estimated USD 2.0 — 2.3 billion of DARZALEX net sales in 2018. We project DARZALEX milestones of approximately DKK 550 million in 2018, consisting primarily of a commercial net sales-based milestone, compared to DKK 1,109 million in 2017. In addition, the 2018 guidance includes the one-time payment from Novartis of approximately DKK 300 million related to the transition of Arzerra from commercial availability to compassionate use programs in non-US markets. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody milestones.

The overall increase in revenue compared to 2017 is primarily due to a one-time payment from Novartis combined with higher DARZALEX royalties which were partly offset by a decrease in DARZALEX milestones.

Operating Result
We anticipate that our 2018 operating expenses will be in the range of DKK 1,400 — 1,600 million, compared to 2017 operating expenses of DKK 1,021 million. The increase is driven by the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and an increase in employees to support the expansion of our product pipeline.

We expect the operating income for 2018 to be approximately DKK 1,300 — 1,500 million compared to DKK 1,344 million reported for 2017.

More information on the Risks and Assumptions for the 2018 Financial Guidance can be found in the 2017 Annual Report available on our website www.genmab.com.

Conference Call
Genmab will hold a conference call in English to discuss the results for the full year 2017 today, February 21, 2018 at 6.00 pm CET, 5.00 pm GMT or noon EST. To join the call by phone, dial one of the following numbers and ask for the Genmab conference call:

US: + 1 646 828 8156
UK: + 44 330 336 9411
DK: + 45 35 15 81 21

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

On February 21, 2018 Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, reported that it will present at the following healthcare conferences in March (Press release, IsoTis, FEB 21, 2018, View Source [SID1234524099]):

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On Monday, March 5, 2018 at 4:35 p.m. ET, Glenn Coleman, chief financial officer and corporate vice president of International, will present at the Raymond James 39th Annual Institutional Investors Conference in Orlando, FL. The session will be available through live audio webcast and can be accessed from the Investor section of www.integralife.com.

On Tuesday, March 13, 2018 at 8:30 a.m. ET, Glenn Coleman, chief financial officer and corporate vice president of International, will present at the Barclays Global Healthcare Conference in Miami Beach, FL. The session will be available through live audio webcast and can be accessed from the Investor section of www.integralife.com.

On Wednesday, March 21, 2018 at 10:20 a.m. ET, Dan Reuvers, corporate vice president and president of Codman Specialty Surgical, will present at the Oppenheimer 28th Annual Healthcare Conference in New York City.

On February 21, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic") reported an update regarding its clinical development programs and confirmation of its priorities regarding its lead drug candidates (Press release, ProMetic Life Sciences, FEB 21, 2018, View Source [SID1234524104]).

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PBI-4050 And Follow-On Analogs, PBI-4547 & PBI-4425
"Idiopathic pulmonary fibrosis (IPF) is now priority No.1 for PBI-4050" stated Pierre Laurin, President and CEO of Prometic. "IPF remains to this day a significant unmet medical need affecting hundreds of thousands of patients with an established market value measured in $billions. The clinical efficacy demonstrated so far in multiple phase 2 clinical trials combined with an impressive safety and tolerability profile gives us great confidence in PBI-4050’s ability to efficiently address fibrotic diseases."

Following the outcome of the successful clinical development Type C meeting held with the FDA in early January 2018, the top clinical development program priority is now the phase 3 pivotal clinical trial for PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF). The all comers study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV) or not and will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication for the treatment of IPF. This multinational study, involving multiple sites across the United States, Canada, Australia, the UK and Europe is expected to begin patient enrollment around the 2018 mid-year mark.

Following last year’s confirmation that beneficial clinical effects are sustained during prolonged treatment in subjects suffering from Alström Syndrome in the United Kingdom, further extensions of duration of treatment were announced to Prometic’s on-going phase 2 open label clinical trial. Prometic now announces that it is formally seeking meetings with both the European and the US regulatory authorities to determine the clinical- regulatory pathway for this condition as a stand-alone indication.

Pierre Laurin stated: "We will soon be disclosing further clinical data from the on-going Alström Syndrome clinical trial in the UK which also gives us great confidence to pursue this devastating condition as a stand-alone fibrosis indication to be treated with PBI-4050. Safety and efficacy data collected and demonstrated to date in such a challenging patient population will also contribute to the clinical design and potential treatment for future clinical development initiatives of the Corporation with respect to indications such as heart, kidney & liver fibrosis".

As part of this realignment, the Corporation has terminated PBI-4050 clinical trial in Cystic Fibrosis Related Diabetes ("CFRD") and is evaluating the need to continue other on-going clinical programs with PBI-4050. Prometic is evaluating its clinical development strategy regarding follow-on compounds (i.e. analogs of PBI-4050) which share the same unique mechanism of action with PBI-4050, have demonstrated similar performance in multiple preclinical studies and some of which have outperformed PBI-4050 in specific animal models. Clinical development of those analogs would enable Prometic to target other fibrotic-related indications and create further therapeutic products optionality for our on- going partnering discussions.

These realignments therefore include: The commencing of PBI-4547’s clinical program includes the initiation of the phase 1 clinical trial in Q2 2018 followed by a phase 2 in patients with liver fibrosis and metabolic diseases. It further includes the initiation of PBI- 4425’s clinical program which is scheduled to commence in H2 2018 with specific targeted indications to be communicated in H2 2018.

RyplazimTM For Plasminogen Deficiencies
RyplazimTM (plasminogen) is the first biopharmaceutical expected to be launched commercially pending the review of its BLA (Biologic License Application) submitted to the FDA initially for the treatment of congenital plasminogen deficiency.

The Company will prioritize the expansion of clinical indications for RyplazimTM and leverage the positive clinical experience gained by supplementing plasminogen levels in deficient patients. There are several medical conditions, some of which potentially lethal, associated with "acquired plasminogen deficiencies" and Prometic is designing clinical trials to establish optimal dosing protocols for the potential use of RyplazimTM for the treatment of such conditions, including thrombotic events as well as acute exacerbations in patients with acute respiratory distress syndrome (ARDS) and/or IPF.

Clinical trials with sub-cutaneous Plasminogen in patients with diabetic foot ulcers and in patients with Tympanic perforations are also currently being conducted in Sweden with expected interim clinical data readouts later this year.

The expenses related to the IVIG non-inferiority phase 3 clinical trial will decrease in 2018 with the completion in H1 2018 of the adults’ cohort required for the FDA BLA filing to be followed by the completion of the pediatric cohort in H1 2019.

Commenting on the financing strategy required to execute on these plans, Bruce Pritchard, Prometic’s CFO noted, "At this stage in its development, the Corporation requires a financing strategy that allows it to maintain adequate capitalization as it continues to build enterprise value with its strong pipeline of therapeutics, but that also recognizes the need for a combination of: generating revenue through product sales; generating revenue from leveraging the asset base, such as licensing technologies for non-core indications or geographies and monetizing priority review vouchers; effective use of debt and synthetic royalty structures and by accessing capital from long-term institutional investors under the best possible conditions". He added, "Each element of this plan is critical, and is being actively pursued by management. Investors should be assured that no single component of the strategy is been seen as mutually exclusive to another. Most importantly, all components need to be readily deployable as required, as we continue to plan to execute a timely secondary listing on NASDAQ".

To maintain its flexibility for strategic fund-raising, Prometic has filed a preliminary short form base shelf prospectus (the "Preliminary Shelf Prospectus") with the securities commissions in each of the provinces of Canada.

Mr. Pritchard went on to explain, "The establishment of a shelf prospectus is common practice among our Canadian and US Peers. Prometic is somewhat unusual for not having one in place. Today’s filing of such a shelf prospectus adds to our armory of financing choices".

The Preliminary Shelf Prospectus, when made final or effective, will allow Prometic to offer up to $250,000,000 of common shares over the 25-month period that the Shelf Prospectus is effective. The Shelf Prospectus will enable Prometic to potentially access new capital as and when needed. The amount and timing of any future offerings will be based on the Company’s financial requirements and market conditions at the time. The specific terms of any future offering under the Shelf Prospectus will be established at the time of such offering. At the time any of the securities covered by the Shelf Prospectus are offered for sale, a prospectus supplement containing specific information about the terms of such offering will be filed with applicable Canadian securities regulatory authorities. The Preliminary Shelf Prospectus filed today with the Canadian securities regulatory authorities has not yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the Preliminary Shelf Prospectus becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction. A copy of the Preliminary Shelf Prospectus can be found on SEDAR at www.sedar.com or may be obtained upon request to Prometic’s Investor Relations Department using the contact information set out below.

On February 21, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three and 12 months ended December 31, 2017, and provided an operating forecast and program updates (Press release, Ligand, FEB 21, 2018, View Source [SID1234524100]). 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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"Coming off a strong fourth quarter for our top two royalty assets, Ligand entered 2018 with economic rights to two drugs each on a run rate to exceed $1 billion in sales this year," said John Higgins, Chief Executive Officer of Ligand. "Of particular importance for our investors is that the strong financial momentum of these programs parallels all-time-high demand for our two leading technology platforms, OmniAb and Captisol. The integration of Crystal Bioscience, the company we acquired at the end of 2017, is going extremely well and there is strong interest by our antibody partners for the new OmniChicken platform. In addition to our robust fundamental performance, the new tax law meaningfully increases our long-term outlook for profits and cash flow as our projected tax rate has been reduced by more than a third from what we had been projecting."

Fourth Quarter 2017 Financial Results

Total revenues for the fourth quarter of 2017 were $50.5 million, compared with $38.2 million for the same period in 2016. Royalties were $28.3 million, compared with $19.6 million for the same period in 2016, an increase of 45% primarily due to higher royalties from Promacta, Kyprolis and EVOMELA. Material sales were $7.7 million, compared with $9.1 million for the same period in 2016 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $14.4 million, compared with $9.5 million for the same period in 2016.

Cost of goods sold was $1.7 million for the fourth quarter of 2017, compared with $2.9 million for the same period in 2016. Amortization of intangibles was $4.0 million, compared with $2.7 million for the same period in 2016. Research and development expense was $8.6 million, compared with $6.4 million for the same period of 2016 due to non-cash stock-based compensation expense. General and administrative expense was $7.7 million, compared with $6.8 million for the same period in 2016.

GAAP net loss for the fourth quarter of 2017 was $7.0 million, or $0.33 per diluted share, compared with a GAAP net loss of $3.1 million, or $0.15 per diluted share, for the same period in 2016. GAAP net loss for the fourth quarter of 2017 includes a one-time non-cash charge of $32.8 million due to a reduction in Ligand’s tax assets, which primarily comprise accumulated net operating losses, driven by the lower tax rates of the Tax Cuts and Jobs Act. Adjusted net income for the fourth quarter of 2017 was $29.6 million, or $1.31 per diluted share, compared with adjusted net income of $16.1 million, or $0.74 per diluted share, for the same period in 2016.

As of December 31, 2017, Ligand had cash, cash equivalents and short-term investments of $201.7 million. Cash generated from operations was $31.3 million for the fourth quarter of 2017.

Full Year 2017 Financial Results

Total revenues for 2017 were $141.1 million, compared with $109.0 million for 2016. Royalties were $88.7 million, compared with $59.4 million for 2016, an increase of 49% primarily due to higher royalties from Promacta, Kyprolis and EVOMELA. Material sales were $22.1 million, compared with $22.5 million for 2016 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $30.3 million, compared with $27.0 million for 2016.

Cost of goods sold was $5.4 million for 2017, compared with $5.6 million for 2016 due to the timing and mix of Captisol sales. Amortization of intangibles was $12.1 million, compared with $10.6 million for 2016. Research and development expense was $26.9 million, compared with $21.2 million for 2016 due to costs of our Phase 2 GRA trial and non-cash stock-based compensation expense. General and administrative expense was $28.7 million, compared with $27.7 million for 2016.

GAAP net income for 2017 was $12.6 million, or $0.53 per diluted share, compared with a GAAP net loss of $1.6 million, or $0.08 per diluted share, for 2016. Adjusted net income for 2017 was $72.5 million, or $3.26 per diluted share, compared with adjusted net income of $46.7 million, or $2.15 per diluted share, for 2016.

2018 Financial Guidance

Ligand reported financial guidance for 2018. At this time, Ligand estimates 2018 revenue will be approximately $164 million and will include royalties of approximately $116 million, material sales of approximately $23 million and license fees and milestones of at least $25 million. During 2018, Ligand estimates it could potentially receive up to an additional $20 million of license fees and milestones; however, such payments are based on external events that are out of Ligand’s control so the Company will provide more information about the timing and probability for any additional license fees and milestone revenue expected to be booked in 2018 as the year progresses. These estimates exclude revenue from a partnership, if any, on the GRA diabetes program.

Ligand estimates that cash expenses for 2018 will be in the range of $34 million to $35 million, including additional expenses in 2018 related to the recent acquisition of Crystal Bioscience. Ligand notes that with revenue of $164 million, adjusted earnings per diluted share would be approximately $4.22. The adjusted EPS figure reflects the Company’s fully-taxed adjusted EPS methodology, including a 22% to 24% tax rate, but the Company continues to pay less than 1% cash taxes as it utilizes its over $400 million of remaining net operating losses (NOLs).

Fourth Quarter 2017 and Recent Business Highlights

Promacta/Revolade

Novartis reported fourth quarter 2017 net sales of Promacta/Revolade (eltrombopag) of $255 million, a $77 million or 43% increase over the same period in 2016.
Novartis announced that the 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.
Novartis announced long-term study results supporting the positive safety and efficacy of Promacta in adults with chronic/persistent (6 or more months from diagnosis) immune (idiopathic) thrombocytopenia (ITP) were published in Blood. The study found that a majority of patients maintained a substantial clinical response and many no longer needed concomitant ITP medications.
The U.S. Department of Health and Human Services announced a partnership with Novartis to study Promacta for potential use post-radiation injury affecting platelets.
Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On February 1, 2018, Amgen reported fourth quarter net sales of Kyprolis of $227 million, a $44 million or 24% increase over the same period in 2016. On February 2, 2018, Ono Pharmaceutical Company reported Kyprolis sales in Japan of approximately $16.4 million 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 (CHMP) of the European Medicines Agency (EMA) 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 December 11, 2017, Amgen announced new results at ASH (Free ASH Whitepaper) 2017 showing the positive OS findings from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint of OS, demonstrating that the addition of Kyprolis to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21% versus lenalidomide and dexamethasone alone (Rd) and extended survival by 7.9 months in patients with relapsed or refractory multiple myeloma (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95; p = 0.0045).
On January 17, 2018, Amgen announced that the Journal of Clinical Oncology published the positive OS findings from the final analysis of the Phase 3 ASPIRE trial.
On October 23, 2017, Amgen announced top-line results of the Phase 3 ARROW trial, which showed Kyprolis administered once-weekly at the 70 mg/m2 dose with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than Kyprolis administered twice-weekly at the 27 mg/m2 dose with dexamethasone.
Additional Pipeline and Partner Developments

Sage Therapeutics announced positive top-line results from two Phase 3 trials of brexanolone in severe postpartum depression (PPD) and in moderate PPD. Sage plans to file a New Drug Application (NDA) with the FDA in 2018.
Melinta Pharmaceuticals announced the U.S. launch of the Captisol-enabled intravenous (IV) formulation of Baxdela for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
HanAll Biopharma successfully out-licensed antibody projects that were discovered using the OmniAb platform, triggering $6 million of payments to Ligand.
Aptevo Therapeutics announced it presented preclinical data on OmniAb-derived APVO436 at ASH (Free ASH Whitepaper) 2017, at the World Bispecific Summit and at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics 2017 annual meeting.
OmniAb partner ARMO BioSciences announced the pricing of an initial public offering with gross proceeds of approximately $147 million.
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.
Retrophin announced it presented new data from the open-label extension portion of the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology Kidney Week 2017.
Aldeyra Therapeutics announced enrollment of the first patient in a Phase 2b clinical trial of topical ocular reproxalap for the treatment of dry eye disease.
Aldeyra Therapeutics announced it presented data from its Phase 2 clinical trial of reproxalap in noninfectious anterior uveitis at the American Uveitis Society Fall Meeting.
Viking Therapeutics announced positive results from a 12-week, Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture. Top-line data demonstrated statistically significant, dose-dependent increases in lean body mass ranging from 4.8% to 9.1% following treatment with VK5211. Viking intends to present additional results from the study at an upcoming scientific conference.
Viking Therapeutics announced positive top-line results from a 25-week proof-of-concept study of VK0214 in an in vivo model of X-linked adrenoleukodystrophy (X-ALD) and presented data at the 87th Annual Meeting of the American Thyroid Association.
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.
Sermonix Pharmaceuticals announced completion of a financing to advance towards a Phase 2 clinical trial of lasofoxifene in estrogen receptor positive (ER+) metastatic breast cancer.
Opthea announced the dosing of the first patient in the Phase 2b trial of OPT-302 for wet age-related macular degeneration (AMD) and 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 that new preclinical data on SY-1365, a selective cyclin-dependent kinase 7 (CDK7) inhibitor currently in a Phase 1 clinical trial in advanced solid tumors, showed anti-tumor activity in in vitro and in vivo models of blood cancers.
Internal Research and Development

Ligand announced initiation of an internally funded program to develop contrast agents with reduced renal toxicity for diagnostic imaging procedures through proof-of-concept. 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.
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.
Recent Acquisition

In October 2017, Ligand acquired Crystal Bioscience and its OmniChicken antibody discovery technology for $25 million in cash at closing, up to $10.5 million of success-based milestones and revenue sharing from existing licensees for a defined period. The acquisition initially added four Shots on Goal to Ligand’s portfolio, and the OmniChicken technology may be utilized by multiple current OmniAb partners as they seek to develop antibodies for difficult-to-address epitopes.
New Licensing Deals

Ligand announced worldwide license agreements with Ferring Pharmaceuticals and Glenmark Pharmaceuticals to use the OmniAb platform technologies to discover fully human antibodies. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.
Ligand entered into Captisol Clinical Use Agreements with Syros Pharmaceuticals and with Vaxxas Inc.
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.