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Medpace Holdings, Inc. Reports Third Quarter 2019 Results

On October 28, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the third quarter ended September 30, 2019 (Press release, Medpace, OCT 28, 2019, View Source [SID1234549933]).

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"In the third quarter the business environment remained steady, and cancellations continued at normal levels"

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"In the third quarter the business environment remained steady, and cancellations continued at normal levels," said August J. Troendle, President & Chief Executive Officer.

Third Quarter 2019 Financial Results

Revenue for the three months ended September 30, 2019 increased 20.6% to $216.2 million, compared to $179.3 million for the comparable prior-year period. On a constant currency organic basis, revenue for the third quarter of 2019 increased 21.0% compared to the third quarter of 2018.

Backlog as of September 30, 2019 grew 19.9% to $1.2 billion from $1.0 billion as of September 30, 2018. Net new business awards were $285.4 million, representing a net book-to-bill ratio of 1.32x for the third quarter of 2019, as compared to $227.6 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 third quarter of 2019, total direct costs were $152.1 million, compared to total direct costs of $124.0 million in the third quarter of 2018. Selling, general and administrative (SG&A) expenses were $29.1 million, compared to SG&A expenses of $18.6 million in the third quarter of 2018.

GAAP net income for the third quarter of 2019 was $24.0 million, or $0.63 per diluted share, versus GAAP net income of $19.3 million, or $0.52 per diluted share, for the third quarter of 2018. This resulted in a net income margin of 11.1% and 10.8% for the third quarter of 2019 and 2018, respectively.

EBITDA for the third quarter of 2019 decreased 6.4% to $34.8 million, or 16.1% of revenue, compared to $37.1 million, or 20.7% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the third quarter of 2019 decreased 8.0% from the third quarter of 2018.

Adjusted Net Income for the third quarter of 2019 increased 8.0% to $27.0 million compared to $25.0 million for the comparable prior-year period. Adjusted Net Income per diluted share for the third quarter of 2019 was $0.71, representing an increase of 6.0%, compared to Adjusted Net Income per diluted share of $0.67 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 $79.3 million at September 30, 2019, and the Company generated $64.3 million in cash flow from operating activities during the third quarter of 2019.

Financial Guidance

The Company forecasts 2019 revenue in the range of $840.0 million to $860.0 million, representing growth of 19.2% to 22.1% over 2018 revenue of $704.6 million. GAAP net income for full year 2019 is forecasted in the range of $94.9 million to $99.7 million. Additionally, full year 2019 EBITDA is expected in the range of $144.0 million to $150.0 million.

Based on forecasted 2019 revenue of $840.0 million to $860.0 million and GAAP net income of $94.9 million to $99.7 million, diluted earnings per share (GAAP) is forecasted in the range of $2.51 to $2.64. Adjusted Net Income for 2019 is forecasted in the range of $107.2 million to $112.0 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 $2.85 to $2.97 per share.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, October 29, 2019, to discuss its third quarter 2019 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 7668623.

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, October 29, 2019 until 12:00 p.m. ET on Tuesday, November 12, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 7668623.

Molecular Targeting Technologies, Inc. Receives Global Rights From NIH for Integrin-Targeting Radiotherapeutics to Treat GBM and Lung Cancer

On October 28, 2019 Molecular Targeting Technologies, Inc. (MTTI) reported that the NIBIB (an Institute within the National Institutes of Health (NIH)) has granted MTTI an exclusive worldwide license to commercialize patented technology invented by Drs. Xiaoyuan Chen and Orit Jacobson (Press release, Molecular Targeting Technologies, OCT 28, 2019, View Source [SID1234549932]). This patent portfolio covers a targeted radiotherapeutic 177Lu-EBRGD for integrin expressing cancers including treating Glioblastoma multiforme (GBM) and Non-Small Cell Lung cancer (NSCLC).

The key feature of this technology is the incorporation of a derivative of Evans Blue into RGD peptide radiopharmaceutical which binds to both albumin and integrin thus extends residence time, enabling smaller and less frequent dosing.

"Integrin is highly expressed in both tumor blood vessels and tumor cells in glioblastoma patients. Based on our study using Ga-68 PRGD2, we believe that Lu-177 EBRGD could be the next innovative radiotherapeutic in treating GBM," said Deling Li, MD. Vice Director of Brain Tumor and International Translational Molecular Imaging Center for Brain Tumor (ITMIC-BT), Beijing Tiantan Hospital.

"We are privileged to receive the exclusive global license from NIH," said Chris Pak, President & CEO of MTTI. "Currently, we are already advancing NIH’s EBTATE for treating neuroendocrine tumors and we look forward to moving EBRGD to tackle hard-to-treat cancers such as GBM and NSCLC."

MTTI is a privately held biotechnology company focused on the acquisition and development of novel technologies for treatment and diagnosis of disease. More information: www.mtarget.com.

*Chen H et al. Novel "Add-On" Molecule Based on Evans Blue Confers Superior Pharmacokinetics and Transforms Drugs to Theranostic Agents. J Nucl Med 2017;58:590-597.

KSQ Therapeutics to Present First Data from its Proprietary CRISPRomics Discovery Engine

On October 28, 2019 KSQ Therapeutics, a biotechnology company using CRISPR technology to enable the company’s powerful discovery engine to achieve higher probabilities of success in drug development, reported two upcoming presentations at leading scientific immuno-oncology congresses (Press release, KSQ Therapeutics, OCT 28, 2019, View Source [SID1234549931]). The data demonstrate the capabilities of the company’s proprietary CRISPRomics discovery engine, which allows genome-scale, in vivo validated, unbiased drug discovery.

"There is a significant need for next-generation immuno-oncology therapies as the majority of cancer patients today experience an insufficient response to PD-1/PD-L1 therapies. The data we will be sharing demonstrate the potential of our CRISPRomics discovery platform to systematically identify and validate new cancer therapies for patients with PD-1 refractory solid tumors," said Frank Stegmeier, Ph.D., Chief Scientific Officer at KSQ Therapeutics. "KSQ was founded on the premise that CRISPR-enabled functional genomics can improve on current approaches to drug discovery and, taken together, these poster presentations describing the output of our genome-scale in vivo T-cell screens show that our platform can do this with a high degree of precision and quality, pointing the direction towards promising avenues of drug development."

Presentations include:

At the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper): Comprehensive identification of novel therapeutic targets for treatment of PD-1 resistant solid tumors via a genome-scale CRISPR/Cas9 in vivo T-cell screen – Poster # C101 – Tuesday, October 29 – 3:30-4:00 p.m. – Level 2 Hall D
At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting: An immune-CRISPRomics platform enabling genome-scale and pair-wise combination in vivo T-cell function screens enables comprehensive identification of novel therapeutic targets – Poster # P550 – Saturday, November 9 – 12:35–2:05 p.m. and 7:00-8:35 p.m.

PierianDx Closes Series B Financing Round to Facilitate the Democratization of Clinical Next-Generation Sequencing

On October 28, 2019 PierianDx, the leading clinical genomics informatics company, reported that it has closed a $27 million Series B funding round led by ATW Partners and SJF Ventures that also includes existing investors Health Catalyst Capital, Inova Health Systems, RTI International, and ARUP Laboratories (Press release, PierianDx, OCT 28, 2019, View Source [SID1234549930]).

PierianDx provides a SaaS platform that enables the practice of clinical genomics as a standard of care and empowers the world’s most advanced molecular diagnostic labs. Founded in 2014 out of Washington University in St. Louis, PierianDx is focused on advancing cancer diagnostics and making targeted therapeutics more accessible to healthcare systems, laboratories, and patients worldwide.

Dr. Rakesh Nagarajan, Founder and Executive Chairman of PierianDx, said, "PierianDx has grown tremendously over the past 18 months and is continuing to add the clinical expertise and resources necessary to execute on our vision. Our team is uniquely skilled and dedicated to the adoption of clinical NGS around the globe."

Michael L. Sanderson, CEO of PierianDx, said, "Our new capital infusion will accelerate the commercial expansion of PierianDx’s leading clinical genomics platform in the U.S. and global markets throughout Europe, Asia, Australia, Latin America, and North America, as we continue to work with leading sequencer, assay and pharma partners in our explosive space. PierianDx is fueled by making the most advanced clinically actionable cancer care accessible to everyone, regardless of location or ability to pay."

"We are excited about leading the Series B investment in PierianDx. We believe PierianDx will change the way cancer is treated worldwide and we are proud to be investors," said Mr. Kerry Propper, Co-Founder and Managing Partner of ATW Partners.

Inflammatory Breast Cancer (IBC) Research Foundation, Susan G. Komen®, and Milburn Foundation® Raise More Than $850,000 to Take on Aggressive Breast Cancer

On October 28, 2019 Inflammatory Breast Cancer (IBC) Research Foundation, Susan G. Komen, and the Milburn Foundation reported that they have again come together to become a powerful force against inflammatory breast cancer (IBC) – an aggressive subtype of breast cancer that is challenging to diagnose and treat (Press release, IBC Research Foundation, OCT 28, 2019, View Source [SID1234549929]). Together, the organizations raised more than $850,000 for research aimed at finding new, innovative diagnostic tools and treatment options for IBC.

Earlier this year, IBC Research Foundation and Milburn matched all donations to Komen up to $50,000, and far exceeded their goal to raise $250,000 in funds specifically for research into IBC.

IBC is a particularly aggressive form of breast cancer because it can be missed on a mammogram, doesn’t usually present with a lump, is often misdiagnosed, and spreads quickly. In fact, about 30 percent of those diagnosed with IBC are initially diagnosed with metastatic disease, meaning their cancer has already spread to other parts of the body. Clinical trials for new therapies often either restrict enrollment of IBC patients or combine their outcomes with non-IBC patients, limiting our understanding of this form of breast cancer.

Through this partnership, a focus group of clinicians, researchers and advocates who are experts in the field of IBC convened to identify the most critical questions in IBC and IBC research. Through this patient directed conversation, several vital challenges were identified, including how inflammatory breast cancer is defined in the clinic and for research. The group has developed a set of recommendations to address the challenge of diagnosis, which will be presented at the San Antonio Breast Cancer Symposium in December.

"In our twenty years of IBC research and patient advocacy, we have consistently stressed the need for better definition and diagnostic guidelines for IBC," said Ginny Mason, Executive Director of the IBC Research Foundation. "We are very pleased that this year’s impressive matching campaign will support continued collaborative work to resolve these long-standing issues, resulting in more timely diagnosis and hopefully saving lives that would have been stolen by IBC."

"We know treatment options for IBC are lacking, and with few clinical trials focused solely on IBC, there have been few improvements in treatment," said Paula Schneider, President and CEO of Susan G. Komen. "We must continue to make IBC and metastatic breast cancer a research priority in order to help save the more than 42,000 lives lost each year in the U.S. to metastatic breast cancer. Partnerships like this help us make an even greater impact than we ever could alone."

"By working hard together, this partnership has amplified the strengths of each organization to bring a potentially significant advancement in IBC to fruition," said Bryon Davis, President and CEO of the Milburn Foundation. "Our collective work being presented at the San Antonio Breast Cancer Symposium is the first of multiple critical milestones aimed at changing the research landscape in IBC."

The partnership between the three organizations has now raised more than $2.44 million to date, thanks to earlier matching gift campaigns beginning in 2016. Funds raised have made it possible to invest in breakthrough research, including studies in IBC, aggressive and metastatic breast cancers.