On May 7, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage oncology company, reported financial results for the first quarter ended March 31, 2018 (Press release, Mirati, MAY 7, 2018, View Source [SID1234526170]).

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"We have made significant progress in all of our programs and continue to be encouraged by positive clinical results for sitravatinib and mocetinostat with planned data presentations at a fall oncology conference," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Additionally, we are on track to file our planned Investigational New Drug application (IND) for MRTX849, a potent and selective inhibitor for KRAS, in the fourth quarter of 2018."

Financial Results for the First Quarter 2018

Cash, cash equivalents, and short-term investments were $148.7 million at March 31, 2018, compared to $150.8 million at December 31, 2017.

License and collaboration revenues for the first quarter of 2018 were $9.5 million, compared to none in the same period in 2017. License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), which became effective January 7, 2018, under which the Company granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in Asia (excluding Japan and certain other countries).

Research and development expenses for the first quarter of 2018 were $19.7 million, compared to $14.4 million for the same period in 2017. The increase in research and development expenses is primarily due to an increase in third party research and development expense for sitravatinib due to the continuation and expansion of ongoing clinical trials. The increase is also related to continued development of our KRAS inhibitor program for costs associated with preparing to file a planned IND application for our selected lead clinical compound, MRTX849. These increases are partially offset by a decrease in glesatinib expenses.

General and administrative expenses for the first quarter of 2018 were $5.2 million, compared to $3.7 million for the same period in 2017. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three months ended March 31, 2018 compared to the same period in 2017.

Net loss for the first quarter of 2018 was $14.7 million, or $0.51 per share basic and diluted, compared to net loss of $17.8 million, or $0.73 per share basic and diluted for the same period in 2017.

On May 7, 2018 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer,reported financial results for the quarter ended March 31, 2018 (Press release, MacroGenics, MAY 7, 2018, View Source [SID1234526169]).

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"Our momentum continues to build in 2018, as our multiple product candidates advance toward data read-outs," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "During the first quarter, margetuximab passed an interim futility analysis for the SOPHIA Phase 3 metastatic breast cancer study. We also presented clinical data for the combination of margetuximab with an anti-PD-1 agent showing encouraging activity in the treatment of gastric cancer patients in a Phase 2 study. We plan to provide an update on this study, including presentation of biomarker data, at the upcoming ASCO (Free ASCO Whitepaper) meeting. During the second half of the year, we expect to provide clinical updates on both flotetuzumab in patients with relapsed/refractory acute myeloid leukemia (AML), and on the combination of enoblituzumab with an anti-PD-1 agent. In addition, we anticipate that two of our oncology product candidates will move into our clinical pipeline this year: MGD019 (PD-1 x CTLA-4 DART molecule) and MGC018 (B7-H3 ADC), the planned investigational new drug (IND) application submissions for which are both on track."

Key Pipeline Updates

Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody (mAb) that targets the human epidermal growth factor receptor 2, or HER2, include:

Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. In January 2018, the Company announced the completion of a pre-planned interim futility analysis with the recommendation of an independent data safety monitoring committee to continue SOPHIA as planned without modification. This analysis was based on a pre-specified assessment of progression-free survival as determined by independent central review. The Company also announced that the U.S. FDA had granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. MacroGenics remains on track to complete enrollment of the study in the fourth quarter of 2018, with anticipated disclosure of topline progression-free survival data in the first half of 2019.

Phase 2 Gastric Cancer Study. In January 2018, MacroGenics presented interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with gastric and gastroesophageal junction (GEJ) cancer. These results included encouraging tolerability and anti-tumor activity in a subpopulation of 25 gastric cancer patients. Based on these results, MacroGenics expanded the study and is enrolling 25 additional gastric cancer patients. The Company will present updated clinical and biomarker data at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting in June.

Exhibit 99.1

Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:

Monotherapy Study. MacroGenics has completed the enrollment of its AML dose expansion cohort. The Company anticipates presenting updated clinical data and defining a potential registration path during the second half of 2018. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

Planned Combination Study with an anti-PD-1. MacroGenics has previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab. MacroGenics intends to initiate a combination study with INCMGA0012, an anti-PD-1 mAb also known as MGA012, during the third quarter of 2018.
Other Pipeline Assets Update
Additional programs that the Company is advancing include the following:
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing multiple PD-1-directed programs to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. These programs include:

INCMGA0012. INCMGA0012 is a humanized, proprietary anti-PD-1 mAb being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. INCMGA0012 was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics transferred the INCMGA0012 U.S. IND to Incyte during the first quarter of 2018.

MGD013. MacroGenics designed a DART molecule, MGD013, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MGD013 is currently being evaluated in a Phase 1 dose escalation study. MacroGenics expects to establish the dose and schedule for MGD013 administration as well as initiate dose expansion cohorts in the second half of 2018.

MGD019. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4 on T cells. The Company is completing IND-enabling studies and anticipates submitting the IND application for MGD019 in the second half of 2018.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

Enoblituzumab: The Company completed the recruitment of patients with four solid tumor types in an ongoing study of this Fc-optimized mAb that targets B7-H3, in combination with an anti-PD-1 mAb and expects to present clinical data from this study in the second half of 2018.

MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate monotherapy dose expansion cohorts in the second half of 2018. In addition, a combination study of MGD009 and INCMGA0012 was initiated during the first quarter of 2018.

Exhibit 99.1

MGC018: The Company is completing IND-enabling activities to support submission of an IND application for this anti-B7-H3 antibody drug conjugate (ADC) and anticipates initiation of a Phase 1 study in the second half of 2018.
Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development being led by MacroGenics include the following:

MGD007. The Company recently completed a monotherapy study of MGD007, a DART molecule that recognizes gpA33 and CD3, and anticipates commencing a combination study with INCMGA0012 in the second quarter of 2018.

MGD014. MacroGenics’ first DART molecule designed to target an infectious agent, MGD014 recognizes the envelope protein of HIV-infected cells (Env) and the T cells’ CD3 component, to redirect the immune system’s T cells to kill HIV-infected cells. The Company expects to commence the Phase 1 study during the second quarter of 2018.

Corporate Update

Roche Collaboration. In January 2018, MacroGenics announced that it had entered into a research collaboration and license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche) to jointly discover and develop novel bispecific molecules to undisclosed targets. MacroGenics received an upfront payment of $10 million from Roche in January 2018 and is eligible to receive potential milestone payments and royalties on future sales.

GMP Manufacturing Suite Build-out: The Company is expanding its manufacturing capacity by completing the build-out of a GMP suite in its headquarters building in Rockville, Maryland to support larger-scale clinical and commercial manufacturing. MacroGenics expects to commence GMP production runs in this facility in the third quarter of 2018.

Common Stock Financing. On April 2, 2018, the Company closed its public offering of 5,175,000 shares of common stock. Net proceeds to MacroGenics, after deducting underwriting discounts and commissions and offering expenses, were $103 million.
First Quarter 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2018, were $260.1 million, compared to $305.1 million as of December 31, 2017.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $4.7 million for the quarter ended March 31, 2018, compared to $2.1 million for the quarter ended March 31, 2017. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.

R&D Expenses: Research and development expenses were $45.7 million for the quarter ended March 31, 2018, compared to $32.8 million for the quarter ended March 31, 2017. This increase was primarily due to the continued enrollment in the Company’s two margetuximab studies and the INCMGA0012 monotherapy clinical trial.

G&A Expenses: General and administrative expenses were $9.2 million for the quarter ended March 31, 2018, compared to $7.5 million for the quarter ended March 31, 2017. This increase

Exhibit 99.1

was primarily due to consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system.
Net Loss: Net loss was $49.5 million for the quarter ended March 31, 2018, compared to net loss of $37.7 million for the quarter ended March 31, 2017.

Shares Outstanding: Shares outstanding as of March 31, 2018 were 37,024,623.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended March 31, 2018 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 1647389.
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On May 7, 2018 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the first quarter ended March 31, 2018 (Press release, Lipocine, MAY 7, 2018, View Source [SID1234526168]).

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First Quarter and Recent Corporate Highlights

The Company received $10 million through a Loan and Security Agreement with Silicon Valley Bank ("SVB Loan").
·The Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") met to discuss the New Drug Application ("NDA") for TLANDO, Lipocine’s oral testosterone product candidate for the proposed indication of testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
BRUDAC voted six in favor and thirteen against the acceptability of the overall benefit/risk profile to support approval of TLANDO as a testosterone replacement therapy ("TRT").
·The Company and the other defendants entered into a memorandum of understanding to settle the purported securities class action litigation captioned In re Lipocine Inc. Securities Litigation.
·The Company initiated a phlebotomy clinical study under the TLANDO investigational new drug ("IND") Application to confirm no ex-vivo conversion of testosterone undecanoate to testosterone.
·The Company submitted a draft protocol for an ambulatory blood pressure monitoring ("ABPM") clinical study to the FDA for review under the TLANDO IND.
The FDA’s assigned Prescription Drug User Fee Act ("PDUFA") goal date for the TLANDO NDA is May 8, 2018.

"We look forward to learning the FDA outcome on our PDUFA goal date for TLANDO. We continue to believe that as an oral drug TLANDO offers significant benefits to patients compared to topical gels and injections. These benefits include overcoming the inadvertent testosterone transference risk to children and partners that exist with topical gels," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.

First Quarter 2018 Financial Results

Lipocine reported a net loss of $2.7 million, or ($0.13) per diluted share, for the quarter ended March 31, 2018, compared with a net loss of $4.9 million, or ($0.26) per diluted share, in the quarter ended March 31, 2017.

License revenues were $428,000 during the three months ended March 31, 2018, compared to no revenue being received during the three months ended March 31, 2017. License revenue relates to royalty payments received from Spriaso, LLC under a licensing agreement for the cough and cold field.

Research and development expenses were $1.4 million in the quarter ended March 31, 2018, compared with $3.1 million in the quarter ended March 31, 2017. The decrease in research and development expenses was primarily due to reduced contract research organization costs for TLANDO and lower personnel costs offset by increased outside service costs primarily related to the TLANDO BRUDAC meeting in January 2018 and increased contract manufacturing costs for LPCN 1107.

General and administrative expenses were $1.7 million in the quarter ended March 31, 2018, compared with $1.8 million in the quarter ended March 31, 2017. The decrease in general and administrative expenses was primarily due to decreased personnel costs and overhead costs offset by increased professional fees related to legal, intellectual property and commercial activities.

As of March 31, 2018, the Company had cash, cash equivalents, and marketable securities of $27.8 million, compared to cash, cash equivalents, and marketable securities of $21.5 million at December 31, 2017. In the event TLANDO is not approved by the FDA on or prior to May 31, 2018, the SVB loan requires $5.0 million of cash to be restricted and held as cash collateral until such time as TLANDO is approved by the FDA.

On May 7, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter ended March 31, 2018 (Press release, Diplomat Speciality Pharmacy, MAY 7, 2018, View Source [SID1234526166]). All comparisons, unless otherwise noted, are to the quarter ended March 31, 2017.

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First Quarter 2018 Highlights include:

Revenue of $1,342 million, compared to $1,079 million, an increase of 24%
Specialty segment revenue of $1,153 million, compared to $1,079 million
PBM segment revenue of $191 million, which was not part of the business in the prior year period
Specialty segment total prescriptions dispensed of 223,000, compared to 220,000
PBM segment total volume, adjusted to 30-day equivalent, of 2,181,000
Gross margin of 8.2% versus 7.9%
Specialty segment gross margin of 8.1% versus 7.9%
PBM segment gross margin of 9.2%
EPS of $(0.01) per diluted common share versus $0.06
Adjusted EPS of $0.20 versus $0.19
Adjusted EBITDA of $39.6 million, compared to $26.8 million
Adjusted EBITDA margin of 3.0% versus 2.5%
Net cash provided by operating activities was $48.6 million, compared to $44.3 million
Net debt, including contingent consideration, reduced to $601.5 million, from $648.7 million at December 31, 2017
Jeff Park, Interim CEO, commented "Diplomat reached a new high mark this quarter in which the incredible team we’ve built executed on our plan and achieved record revenues. Our first quarter demonstrated strong performance in both our Specialty segment and our PBM segment – relaunched last week under its new brand, CastiaRx. Our PBM integration has progressed rapidly, and as our innovation, growth and profitability initiatives continue to gain momentum, we believe we can drive substantial market share gains over time and generate long term value for all our stakeholders."

First Quarter Financial Summary:

Revenue for the first quarter of 2018 was $1,342 million, compared to $1,079 million in the first quarter of 2017, an increase of $263 million or 24%. Revenue was comprised of $1,153 million and $191 million from our Specialty segment and our newly formed Pharmacy Benefit Management ("PBM") segment, respectively. There was a $2.0 million inter-company elimination of revenue, and associated cost of sales, between the segments. The increase in our Specialty segment revenue was primarily driven by $31 million of revenue from our other acquisitions as well as manufacturer price increases, access to dispense drugs that were new in the past year and increased volume through payor relationships. These increases were partially offset by a decrease in hepatitis C business versus the prior year period and drug mix.

Gross profit in the first quarter of 2018 was $110.6 million and generated an 8.2% gross margin, compared to $85.0 million gross profit and 7.9% gross margin in the first quarter of 2017. Gross profit was comprised of $93.0 million and $17.6 million from our Specialty segment and PBM segment, respectively. The gross margin increase in the quarter was primarily due to the impact of our PBM acquisitions, which includes all contracts reflected on a net revenue basis with associated product and service cost of goods, as well as the impact of the acquired entities in our Specialty segment, and manufacturer price increases in the first quarter of 2018 versus the prior year period.

Selling, general, and administrative expenses ("SG&A") for the first quarter of 2018 were $101.9 million, an increase of $25.4 million, compared to $76.5 million in the first quarter of 2017. This increase is primarily driven by $11.5 million related to employee cost, including employee cost for our acquired entities and stock option compensation. Also contributing to the SG&A expense increase was a $7.5 million increase in amortization expense from definite-lived intangible assets, including the capitalized software for internal use, associated with our acquired entities and a one-time $2.1 million severance and merger and acquisition expense associated with our acquired entities. We also experienced increases in other SG&A; including, freight, building and equipment, travel, insurance, and other miscellaneous expenses.

Net (loss) income attributable to Diplomat for the first quarter of 2018 was $(0.5) million compared to $4.4 million in the first quarter of 2017. This decrease was primarily driven by an $8.4 million increase in interest expense due to a significant increase in outstanding debt to fund our PBM acquisitions, partially offset by an income tax benefit of $0.9 million in the first quarter of 2018 versus income tax expense of $2.3 million in the prior year period. The income tax benefit during the first quarter of 2018 was inclusive of a $0.3 million excess tax benefit related to share-based awards. Adjusted EBITDA for the first quarter of 2018 was $39.6 million compared to $26.8 million in the first quarter of 2017, an increase of $12.8 million.

Earnings per share for the first quarter of 2018 was $(0.01), compared to $0.07 for the first quarter of 2017. On a diluted basis, earnings per share was $(0.01) in the first quarter of 2018, compared to $0.06 in the prior year period. Diluted non-GAAP adjusted earnings per share ("Adjusted EPS") was $0.20 in the first quarter of this year compared to $0.19 in the first quarter of 2017.

2018 Financial Outlook

For the full-year 2018, we are increasing our revenue guidance to account for the earlier than anticipated transition to account for revenue in our PBM segment on a gross basis. We are maintaining our previous financial guidance on all other financial measures:

Revenue between $5.5 and $5.9 billion, versus the previous range of $5.3 and $5.6 billion
Net income attributable to Diplomat between $4.5 and $13.0 million
Adjusted EBITDA between $164 and $170 million
Diluted EPS between $0.06 and $0.17
Adjusted EPS between $0.87 and $0.97
Our EPS and Adjusted EPS expectations assume approximately 74,900,000 weighted average common shares outstanding on a diluted basis and a tax rate of 24% and 27%, for the low- and high-end of the range, respectively, for the full year 2018, which could differ materially.

Earnings Conference Call Information

The Company will now hold a conference call to discuss its first quarter performance tomorrow morning, May 8, 2018, at 8:00 a.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (647-689-4450 for international callers) and referencing participant code 5178318 approximately 15 minutes prior to the call. A webcast and audio file of the conference call will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is

On May 7, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the Company has initiated its pivotal trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, MAY 7, 2018, View Source;p=RssLanding&cat=news&id=2347300 [SID1234526165]). Duke Medical Center in Durham, North Carolina is the first cancer center to open for patient enrollment. Dr. Sabino Zani, a surgical oncologist with Duke Medical Center, is serving as the principal investigator for the trial in the United States.

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The trial, entitled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The trial is being conducted under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA) in March 2017. Under the terms of the SPA, the primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. The SPA agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS.

"The ALIGN Trial is based on a strong efficacy signal observed in the ICC tumor type through our commercial experience with CHEMOSAT in Europe," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "The sequential design of the therapies under investigation in the trial will allow us to minimize capital investment requirements in 2018. We are also leveraging our existing network of trial sites from our FOCUS Phase 3 trial to rollout the trial protocol as efficiently as possible, and intend to conduct the trial in a financially prudent manner. In this orphan population where there exists a huge unmet need, this trial provides us with a second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for the Company."