On April 29, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the first quarter ended March 31, 2019 (Press release, Medpace, APR 29, 2019, View Source [SID1234535442]).

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First Quarter 2019 Financial Results

Revenue for the three months ended March 31, 2019 increased 23.1% to $200.7 million, compared to $163.1 million for the comparable prior-year period. On a constant currency organic basis, revenue for the first quarter of 2019 increased 23.7% compared to the first quarter of 2018.

Backlog as of March 31, 2019 grew 21.8% to $1.1 billion from $909.5 million as of March 31, 2018. Net new business awards were $248.7 million, representing a net book-to-bill ratio of 1.24x for the first quarter of 2019, as compared to $200.7 million for the comparable prior-year period. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the first quarter of 2019, total direct costs were $145.7 million, compared to total direct costs of $117.3 million in the first quarter of 2018. Selling, general and administrative (SG&A) expenses were $21.3 million, compared to SG&A expenses of $16.0 million in the first quarter of 2018.

GAAP net income for the first quarter of 2019 was $19.2 million, or $0.51 per diluted share, versus GAAP net income of $14.6 million, or $0.40 per diluted share, for the first quarter of 2018. This resulted in a net income margin of 9.6% and 8.9% for the first quarter of 2019 and 2018, respectively.

EBITDA for the first quarter of 2019 increased 12.7% to $33.4 million, or 16.7% of revenue, compared to $29.7 million, or 18.2% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the first quarter of 2019 increased 9.2% from the first quarter of 2018.

Adjusted Net Income for the first quarter of 2019 increased 18.9% to $23.8 million compared to $20.0 million for the comparable prior-year period. Adjusted Net Income per diluted share for the first quarter of 2019 was $0.64, representing an increase of 16.4%, compared to Adjusted Net Income per diluted share of $0.55 for the comparable prior-year period.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA, EBITDA margin, Adjusted Net Income, and Adjusted Net Income per diluted share to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $30.1 million at March 31, 2019, and the Company generated $34.0 million in cash flow from operating activities during the first quarter of 2019.

In February 2016, the Financial Accounting Standards Board issued ASU 2016-02, "Leases (Topic 842)" ("ASC 842"). The guidance in ASC 842 supersedes the lease recognition requirements in ASC Top 840, Leases (FAS 13). The objective of ASC 842 is to increase transparency and comparability among organizations by requiring the recognition of Right of use assets and Lease liabilities on the balance sheet. ASC 842 became effective for the Company in the first quarter of 2019. The impact of the adoption of ASC 842 as of January 1, 2019 is as follows:

Financial Guidance

The Company forecasts 2019 revenue in the range of $813.0 million to $837.0 million, representing growth of 15.4% to 18.8% over 2018 revenue of $704.6 million. GAAP net income for full year 2019 is forecasted in the range of $85.2 million to $89.2 million. Additionally, full year 2019 EBITDA is expected in the range of $137.0 million to $145.0 million.

Based on forecasted 2019 revenue of $813.0 million to $837.0 million and GAAP net income of $85.2 million to $89.2 million, diluted earnings per share (GAAP) is forecasted in the range of $2.27 to $2.38. Adjusted Net Income for 2019 is forecasted in the range of $97.0 million to $101.0 million, compared to Adjusted Net Income of $95.5 million for 2018. Furthermore, Adjusted Net Income per diluted share for 2019 is expected in the range of $2.58 to $2.69 per share.

Conference Call Details

Medpace will host a conference call at 8:30 a.m. ET, Tuesday, April 30, 2019, to discuss its first quarter 2019 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 8067378.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available at 12:00 p.m. ET on Tuesday, April 30, 2019 until 12:00 p.m. ET on Tuesday, May 14, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 8067378.

On April 29, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2019 first quarter financial results on Tuesday, May 7, 2019, before the market opens (Press release, Eagle Pharmaceuticals, APR 29, 2019, View Source [SID1234535549]).

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Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date Tuesday, May 7, 2019
Time
8:30 a.m. EDT

Toll free (U.S.) 877-876-9176
International 785-424-1670
Webcast (live and replay)
www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-5493 (US) or 402-220-2552 (International) and entering conference call ID EGRXQ119. The webcast will be archived for 30 days at the aforementioned URL.

On April 29, 2019 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported that it will be presenting at the following pharmaceutical industry and financial events in Q2 2019 (Press release, NicOx, APR 29, 2019, View Source [SID1234535676]):

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Michele Garufi, Chairman and CEO, will present at the 2019 Ophthalmology Innovation Summit (OIS) on May 2, 2019, prior to the 2019 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The conference is being held at the Hilton San Diego Bayfront in San Diego, U.S.
Gavin Spencer, Chief Business Officer, will present at the JMP Securities Life Sciences Conference on June 20, 2019 to be held at the St. Regis hotel in New York, U.S.
Emmet Purtill, Senior Director of Business Development, will present at the BIO 2019 International Convention to be held from June 3-6, 2019 in Philadelphia, U.S.

The presentations will be available on the Nicox website (www.nicox.com) in the "Presentations & Events" section.

Nicox management will also participate in the following events for 1:1 meetings with investors:

May 16: European MidCap Event, Copenhagen, Denmark
June 18-19: European MidCap Event, Paris, France
June 24-25: HealthTech Investor Day, Paris, France

On April 29, 2021 Vibliome Therapeutics, LLC, reported that it closed a $16mm Series A round of financing to advance its proprietary technology supporting the development of small molecule therapeutics targeting clinically-relevant signaling pathways (Press release, Vibliome, APR 29, 2019, View Source [SID1234580056]).

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Deerfield Management was the sole investor in the Series A financing round and will be providing operational support. Vibliome has discovered a new systematic approach for the development of small molecule kinase inhibitors with unique profiles and a very high degree of selectivity. The company’s focus on medicinal chemistry gives it a distinct advantage in developing high quality inhibitors against exciting new targets. Vibliome’s technology also supports lead generation for improved inhibitors against validated and novel targets by taking advantage of new mechanisms of binding and dierentiated target combinations. This platform technology is ideally suited to support emerging therapeutic approaches for cancer and other diseases where selective enzyme targeting is needed.

There are over 500 kinases encoded by the human genome which control nearly all cellular functions by phosphorylating proteins. Aberrations in the control of cell metabolism, division, growth and death are hallmarks in the development of cancer, and kinase inhibitors have been shown to be eective in targeting genetic mutations and fusions that drive cancer progression. "The versatility of our chemistry platform oers many opportunities for variation while maintaining a common general architecture," said Robert Goodwin, Vibliome’s CEO. "We are very excited to leverage Deerfield’s support as we develop new therapeutic options for patients, particularly in oncology."

On April 29, 2019 Beam Therapeutics, a biotechnology company developing precision genetic medicines through base editing, reported the presentation of preclinical data from the company’s base editing platform at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 22nd Annual Meeting being held April 29 – May 2, 2019 in Washington, D.C (Press release, Beam Therapeutics, APR 29, 2019, View Source [SID1234535443]).

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In the experiment, the base editor BE4 demonstrated high efficiency multiplex base editing of three cell surface targets in primary human T cells (TRAC, B2M, and PD-1), knocking out expression of each gene in 95%, 95% and 88% of cells, respectively, in a single electroporation. Editing each of these genes may be useful in the creation of CAR-T cell therapies with improved therapeutic properties. Each of the genes was silenced by a single targeted base change (C to T) without the creation of double strand breaks. As a result, the BE4-treated cells also did not have any measurable translocations (large-scale genomic rearrangements), whereas cells receiving the same three edits with a nuclease did show detectable genomic rearrangements.

"Beam is actively applying base editing across a wide range of serious genetic diseases using both ex vivo and in vivo delivery approaches, and we are pleased to begin sharing some of the research progress in our therapeutic programs," said John Evans, chief executive officer of Beam. "The data presented today underscore one of the exciting emerging applications of base editing technology, which is to enable multiplex editing of CAR-T cells without genomic rearrangements. For advanced cellular therapies requiring a large number of simultaneous edits, base editing represents an important new technology that could open up new options for patients with cancer and other immune-mediated diseases."

Presentation Details:
Title: (#140) Base editors generate allogeneic CAR-T cells with no detectable genomic rearrangements and reduced genotoxicity
Session: CAR T Cell Therapies for Cancer
Date/time: Monday April 29, 2019, 4:00-4:15 p.m.
Room: IBR West