On February 21, 2018 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) today reported its financial results for the fourth quarter and year ended December 31, 2017 and provided a corporate update (Press release, Momenta Pharmaceuticals, FEB 21, 2018, View Source [SID1234524102]).

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"In 2017 we made important progress, despite facing delays and challenges, and we are beginning to see the fruits of our diligent work pay off. With the recent approval and launch of Glatopa 40 mg, the significant advancements we’ve made across our novel drug portfolio, and the furthering of both M923, our biosimilar HUMIRA candidate, and M710, our biosimilar EYLEA candidate in collaboration with Mylan, we are well-positioned for a positive year ahead." said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals.

Wheeler continued, "Operationally, with Sandoz’s launch of Glatopa 40 mg we should gain more clarity on this product’s future revenue potential. The Glatopa 40 mg delay and the entry of another generic COPAXONE 20 mg and 40 mg in 2017, however, has impacted our long-term ability to fund our broad and advancing product pipeline. We initiated a strategic review of our current business to proactively address this challenge, including the potential for new partnerships across our portfolio, additional cost reduction strategies, and the sale of certain assets. Momenta remains focused on maximizing shareholder value and I look forward to updating you on our progress."

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Fourth Quarter Highlights and Recent Events

Complex Generics:

Glatopa 40 mg: a fully substitutable, AP-rated generic version of three-times-a-week COPAXONE 40 mg for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

· On February 13, 2018, Momenta announced that the FDA had approved Sandoz’s Abbreviated New Drug Application for Glatopa 40 mg and that Sandoz initiated the launch of the product in the US.

Glatopa 20 mg: First FDA-approved, substitutable generic daily COPAXONE 20 mg (glatiramer acetate injection) for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

· In the fourth quarter of 2017, Momenta recorded $13.0 million in product revenues from Sandoz’s sales of Glatopa 20 mg, reflecting $13.6 million in profit share, net a deduction of $0.6 million in reimbursement to Sandoz for the Company’s share of Glatopa-related legal expenses.

Enoxaparin Sodium Injection: First FDA-approved, substitutable generic LOVENOX (Enoxaparin Sodium Injection) used for the prevention and treatment of deep vein thrombosis developed in collaboration with Sandoz

· On February 7, 2018, the U.S. District Court of Massachusetts issued its decision in the Company’s patent litigation against Amphastar involving U.S. Patent No. 7,575,886, covering methods for the manufacturing control of generic LOVENOX. In July 2017, the jury in this case issued its verdict finding that the Company’s ‘886 patent was infringed by two separate methods used by Amphastar, but invalid for lack of written description and enablement. The jury also provided the court with an advisory verdict recommending that the court find the patent unenforceable by the Company against Amphastar for both of their infringing methods. This recent court decision narrows the advisory verdict finding the patent to be unenforceable against only one of the two infringing methods used by Amphastar. The Company is evaluating its plans for appeal.

· In the fourth quarter of 2017, Momenta recorded $0.3 million in product revenue on Sandoz’s sales of Enoxaparin Sodium Injection.

Biosimilars:

M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)

· In January 2018, the Company announced that the Biologics License Application (BLA) for M923 is prepared to be filed with the FDA. At this time, the timing of Momenta’s filing of the BLA is dependent on the identification of a collaboration partner for M923.

M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with Mylan

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· In November 2017, Momenta announced that M834 did not meet its primary pharmacokinetic endpoints in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to investigate these results in order to determine the next steps for the program.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

· In January 2018, Momenta and Mylan disclosed that M710 is a proposed biosimilar to EYLEA.

· An Investigational New Drug (IND) application has been accepted and the companies plan to initiate a pivotal clinical trial in patients in the first half of 2018.

Novel Drugs for Autoimmune Indications:

M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

· In January 2018, the Company reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%.

· Momenta is finalizing its development strategy for M281 and is planning to initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

· In late January 2018, CSL began dosing subjects in the Phase 1 trial in healthy volunteers to evaluate the safety and tolerability of M230. The Phase 1 study is expected to be completed within one year.

M254 (hsIVIg): a hyper-sialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg) to remediate limitations of that therapeutic approach

· The Company began an IND-enabling toxicology study in the fourth quarter of 2017 and is targeting the initiation of a clinical trial in the second half of 2018.

Fourth Quarter and Year End 2017 Financial Results

Revenue: In the fourth quarter of 2017, the Company recorded $13.0 million in product revenues from Sandoz’s sales of Glatopa 20 mg reflecting $13.6 million in profit share, net

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a deduction of $0.6 million in reimbursement to Sandoz of the Company’s share of Glatopa-related legal expenses, compared to $15.8 million for the same period in 2016, reflecting $19.4 million in profit share, net a deduction of $3.6 million in reimbursement to Sandoz for the Company’s share of Glatopa-related legal expenses. For the year ended December 31, 2017, the Company recorded $66.5 million in product revenues from Sandoz’s sales of Glatopa 20 mg reflecting $68.2 million in profit share, net a deduction of $1.7 million in reimbursement to Sandoz of the Company’s share of Glatopa-related legal expenses, compared to $74.6 million for the same period in 2016, reflecting $78.1 million in profit share, net a deduction of $3.5 million in reimbursement to Sandoz of the Company’s share of Glatopa-related legal expenses. The decreases in product revenues of $2.8 million, or 18%, and $8.1 million, or 11%, from the fourth quarter of 2016 to the fourth quarter of 2017, and from the year ended 2016 to the year ended 2017, respectively, were primarily due to higher sales deductions for Medicaid rebates and lower net sales from price adjustments relating to Mylan’s entry into the COPAXONE market. In addition, under the terms of the collaboration agreement with Sandoz, a $10.0 million commercial milestone payment Momenta earned from Sandoz in July 2017 was deducted from net profit prior to the calculation of Momenta’s 50% profit share for the year ended 2017.

Research and development revenue for the fourth quarter of 2017 was $51.2 million compared to $18.4 million recorded in the same quarter last year. The increase in research and development revenue of $32.8 million, or 178%, was primarily due to revenue recognition of the $50.0 million upfront payment from CSL in the fourth quarter of 2017, partially offset by revenue of $14.6 million in the fourth quarter of 2016 representing the remaining balance of the upfront and license payments from Baxalta as the Company had no further performance obligations under that collaboration agreement as of December 31, 2016. For the year ended December 31, 2017, research and development revenue was $72.1 million compared to $35.0 million recorded in the same period in 2016. The increase in research and development revenue of $37.1 million, or 106%, resulted from revenue recognition of the $50.0 million upfront payment from CSL and the $10.0 million commercial milestone payment the Company earned on July 1, 2017 in connection with Glatopa 20 mg being the sole FDA-approved generic of COPAXONE at the time and achieving a certain level of contractually defined profits in the United States. These increases were partially offset by revenue of $22.0 million in the 2016 period representing the remaining balance of deferred revenue from Baxalta.

Total revenues for the fourth quarter of 2017 were $64.6 million compared to $34.2 million for the same period in 2016. For the year ended December 31, 2017, total revenues were $138.9 million compared to $109.6 million for the same period in 2016.

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Operating Expenses: Total GAAP operating expenses were $52.0 million in the fourth quarter of 2017. For the year ended December 31, 2017, total GAAP operating expenses were $231.4 million.

Research and development expenses for the fourth quarter of 2017 were $36.1 million, compared to $26.4 million for the same period in 2016. The increase of $9.7 million, or 37%, was primarily due to increased spending on the Company’s biosimilars programs, of which $5.1 million was related to M923 development activities for which Momenta was responsible effective December 31, 2016. For the year ended December 31, 2017, research and development expenses were $149.2 million, compared to $119.9 million for the same period in 2016. The increase of $29.3 million, or 24%, was due to increased spending on the Company’s biosimilars programs of $45.1 million, of which $37.9 million related to M923. These increases were partially offset by decreases in spend of $14.9 million on the Company’s novel therapeutic programs, of which $8.4 million was related to the necuparanib program, which the Company discontinued in August 2016, and $5.4 million was related to M230, as those costs became shared with CSL effective August 2017. Other decreases include the reversal of previously recognized share-based compensation expense associated with performance-based stock awards.

General and administrative expenses for the fourth quarter of 2017 were $15.8 million, compared with $18.2 million for the same period in 2016. The decrease of $2.4 million, or 13%, was primarily driven by lower share-based compensation expense mainly associated with performance-based restricted stock awards. For the year ended December 31, 2017, general and administrative expenses were $82.2 million, compared to $64.5 million for the same period in 2016. The increase of $17.7 million, or 27%, was driven by $15.5 million of legal costs primarily relating to the Company’s ongoing litigation.

Fourth quarter non-GAAP operating expense was $51.6 million, within the range of previously provided guidance of $43 – $53 million. Full year 2017 non-GAAP operating expense was $208.2 million. Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Income (Loss): The Company reported a net income of $13.8 million, or $0.18 per share for the fourth quarter of 2017 compared to a net income of $41.5 million, or $0.60 per share for the same period in 2016. Net income in the 2017 period was driven by the recognition of the $50.0 million upfront payment from CSL as revenue. Net income in the 2016 period

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includes the one-time asset return payment of $51.2 million from Baxalta for the early termination of the M923 collaboration. For the year ended December 31, 2017, the Company reported a net loss of $(88.1) million, or $(1.20) per share compared to a net loss of $(21.0) million, or $(0.31) per share for 2016.

Cash Position: At December 31, 2017, Momenta had $379.9 million in cash, cash equivalents and marketable securities compared to $423.1 million at September 30, 2017.

2018 Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. Today, Momenta is providing non-GAAP operating expense guidance of approximately $180 – $220 million for 2018 and $45 – $55 million for the first quarter of 2018. The Company expects to continue to recognize revenue from Mylan’s $45 million upfront payment on a quarterly basis. The Company also estimates that collaborative reimbursement revenues will be approximately $0 – $2 million per quarter in 2018. The Company’s guidance for 2018 is subject to potential changes in operating plans with respect to the strategic review initiated in January 2018.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense and collaborative reimbursement revenues. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company has provided the estimated reconciling information

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that is available without unreasonable effort in the section of this press release above entitled "2018 Financial Guidance."

Conference Call Information

Management will host a conference call and webcast today at 10:00 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 6799797. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 6799797. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 6799797.

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.

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 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 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Barclays Global Healthcare Conference on Wednesday, March 14, 2018. Joshua Smiley, senior vice president and Lilly’s chief financial officer, will participate in a fireside chat at 8:30 a.m., Eastern Time (Press release, Eli Lilly, FEB 21, 2018, View Source [SID1234524097]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.