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Parker Waichman LLP is Reviewing Allergan’s BIOCELL textured breast implants and Allergan’s BIOCELL Breast Tissue Expander Lymphoma Cases

On July 29, 2019 Allergan reported that issued a worldwide recall of its BIOCELL textured breast implants and BIOCELL tissue expanders following reports of women being diagnosed with cancer, with some cases resulting in death (Press release, Allergan, JUL 29, 2019, View Source [SID1234537866]). The company’s recall followed an FDA Safety Alert and an FDA Recall Request.

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Allergan, a medical device manufacturer, has recalled all of its BIOCELL textured breast implants and tissue expanders, removing the products from the market worldwide. The recall was announced after the United States Food and Drug Administration (FDA) reported a significant increase in the number of cases of women with Allegan’s BIOCELL textured breast implants who have been diagnosed with breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

The affected BIOCELL textured breast implants and BIOCELL tissue connectors have already been recalled by three dozen countries worldwide. The FDA reports that there is now a total of 573 cases of BIA-ALCL worldwide in women who had Allergan BIOCELL textured breast implants, with 33 of these women dying from cancer. The FDA also states that women with Allergan BIOCELL textured breast implants are 6 times more likely to develop BIA-ALCL than with similar breast implants manufactured by other medical device companies in the United States.

Specific BIOCELL Textured Breast Implants and Tissue Connectors Subject to Recall

Allergan’s recall of its BIOCELL textured breast implants includes the following products:

Natrelle saline-filled breast implants;
Natrelle silicone-filled breast implants;
Natrelle Inspira silicone-filled breast implants; and
Natrelle 410 Highly Cohesive Anatomically Shaped silicone-filled breast implants.
Allergan’s recall of its BIOCELL tissue expanders includes the following products:

Biocell Tissue Expanders:
Natrelle 133 Plus Tissue Expander; and
Natrelle 133 Tissue Expander with Suture Tabs.
All unused products will be removed from shelves. Women with any of the above-listed breast implants are instructed to see their doctor if they have any swelling or pain near the breast implant. Women are not instructed to have the breast implants removed if they do not have any symptoms.

Parker Waichman LLP is Offering a Free Legal Claim Review

Parker Waichman LLP is helping victims recover monetary compensation for lymphoma caused by Allergan’s BIOCELL textured breast implants and tissue connectors. If you or a loved one are diagnosed with breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), call Parker Waichman LLP to hold Allergan responsible by filing a civil lawsuit. For more information, please contact attorney Jerrold S. Parker at Parker Waichman LLP through the firm’s website YourLawyer.com or by calling 1-800-YOURLAWYER (1-800-968-7529).

Castle Biosciences Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On July 29, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), reported the closing of its previously announced initial public offering of 4,600,000 shares of its common stock, which includes 600,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $16.00 per share (Press release, Castle Biosciences, JUL 29, 2019, View Source [SID1234537860]). Including the option exercise, the gross proceeds to Castle Biosciences from the offering, before deducting the underwriting discounts and commissions and offering expenses, were $73.6 million.

SVB Leerink and Baird acted as joint book-running managers for the offering and as representatives of the underwriters. Canaccord Genuity and BTIG acted as co-managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on July 24, 2019. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone: (800) 808‐7525, ext. 6132, or by e‐mail: [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, by telephone: (800) 792-2473, or by email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Medpace Holdings, Inc. Reports Second Quarter 2019 Results

On July 29, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the second quarter ended June 30, 2019 (Press release, Medpace, JUL 29, 2019, View Source [SID1234537859]).

"In the second quarter, the business environment remained strong, and our competitive win rate remained healthy," said August J. Troendle, President & Chief Executive Officer. "Cancellations in the quarter returned to an anticipated historical range from elevated levels the past two quarters."

Second Quarter 2019 Financial Results

Revenue for the three months ended June 30, 2019 increased 25.8% to $214.1 million, compared to $170.1 million for the comparable prior-year period. On a constant currency organic basis, revenue for the second quarter of 2019 increased 26.0% compared to the second quarter of 2018.

Backlog as of June 30, 2019 grew 19.6% to $1.2 billion from $979.7 million as of June 30, 2018. Net new business awards were $279.2 million, representing a net book-to-bill ratio of 1.30x for the second quarter of 2019, as compared to $239.9 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 second quarter of 2019, total direct costs were $150.3 million, compared to total direct costs of $116.7 million in the second quarter of 2018. Selling, general and administrative (SG&A) expenses were $23.6 million, compared to SG&A expenses of $20.5 million in the second quarter of 2018.

GAAP net income for the second quarter of 2019 was $27.5 million, or $0.73 per diluted share, versus GAAP net income of $16.6 million, or $0.45 per diluted share, for the second quarter of 2018. This resulted in a net income margin of 12.8% and 9.7% for the second quarter of 2019 and 2018, respectively.

EBITDA for the second quarter of 2019 increased 20.3% to $40.2 million, or 18.8% of revenue, compared to $33.4 million, or 19.7% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the second quarter of 2019 increased 18.2% from the second quarter of 2018.

Adjusted Net Income for the second quarter of 2019 increased 35.7% to $30.4 million compared to $22.4 million for the comparable prior-year period. Adjusted Net Income per diluted share for the second quarter of 2019 was $0.81, representing an increase of 32.8%, compared to Adjusted Net Income per diluted share of $0.61 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 $20.1 million at June 30, 2019, and the Company generated $46.6 million in cash flow from operating activities during the second quarter of 2019. Additionally, the Company paid off its remaining outstanding obligations against its term loan during the second 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 $93.4 million to $97.4 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 $93.4 million to $97.4 million, diluted earnings per share (GAAP) is forecasted in the range of $2.49 to $2.60. Adjusted Net Income for 2019 is forecasted in the range of $105.7 million to $109.7 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 $2.82 to $2.93 per share.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, July 30, 2019, to discuss its second quarter 2019 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 6197355.

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, July 30, 2019 until 12:00 p.m. ET on Tuesday, August 13, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 6197355.

Arcus Biosciences to Present at Upcoming Investor Conferences

On July 29, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that members of the management team will participate in the following upcoming investor conferences (Press release, Arcus Biosciences, JUL 29, 2019, View Source [SID1234537858]):

BTIG Biotechnology Conference on Monday, August 12, 2019, at 12:00 pm Eastern Time in New York. Juan Jaen, Ph.D., President, will participate in a panel discussion entitled, "Solid Tumors Beyond PD-1 Monotherapy."
2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019, at 8:35 am Eastern Time in New York. Juan Jaen, Ph.D., President, and Rekha Hemrajani, Chief Operating Officer and Chief Financial Officer, will participate in a fireside chat. To access the live audio webcast of the fireside chat, please visit the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for 30 days following the live event.

Verastem Oncology Appoints Brian Stuglik as Chief Executive Officer

On July 29, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Brian Stuglik, a member of the Board of Directors, has been named Chief Executive Officer (CEO) (Press release, Verastem, JUL 29, 2019, View Source [SID1234537857]).

"Brian brings deep commercial and biopharmaceutical leadership experience that we believe will accelerate the growth of COPIKTRA and progress overall company goals," said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. "Throughout his career, Brian has demonstrated an ability to deliver results through a clear strategic vision, focused teams and excellent execution. We are confident that he will capitalize on the significant opportunities in front of the company on behalf of patients, customers and our shareholders."

Mr. Stuglik has more than three decades of experience in US and International pharmaceutical development, product strategy and commercialization, with a focus on Oncology. He spent the majority of his career at Eli Lilly and Company, culminating in his role as Global Vice President and Chief Marketing Officer, Oncology Global Marketing, advancing Lilly Oncology from a single approved product to a portfolio of marketed or late-stage compounds across more than 10 cancer types. In May of this year, he took on a strategic oversight and advisory role to Verastem Oncology’s commercial organization.

"I am honored to join the Verastem Oncology team as CEO and am energized to build on our commitment to patients as we realize the full potential of COPIKTRA and the pipeline," said Mr. Stuglik. "Being a member of the Board of Directors and, more recently, serving as a strategic partner to the team, I have great confidence in Verastem Oncology’s ability to rapidly progress our mission to improve the lives of cancer patients."

Mr. Stuglik will continue to serve as a member of the Board of Directors and will lead the company’s executive team. As recently announced, Dan Paterson, formerly the Chief Operating Officer has assumed the role of President and Chief Operating Officer and Rob Gagnon has expanded his role to Chief Business and Financial Officer.

As previously announced, the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019.