Histogenics Corporation Appoints E. Lynne Kelley, M.D., FACS As Chief Medical Officer

On July 31, 2018 Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, reported the appointment of E. Lynne Kelley, M.D., FACS as its Chief Medical Officer (Press release, Histogenics, JUL 31, 2018, View Source;p=RssLanding&cat=news&id=2360905 [SID1234528656]). Dr. Kelley brings more than 20 years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to Histogenics. Dr. Kelley will join Histogenics’ executive team and assume responsibility for leading medical affairs strategy and building out the department in anticipation of NeoCart’s potential commercial launch. Dr. Kelley will also work with the team on preparing the anticipated Biologics License Application (BLA) for NeoCart and spearheading related discussions with the United States Food and Drug Administration (FDA).

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"Lynne’s experience as a surgeon, medical affairs executive and educator across a wide variety of therapeutic areas and indications will be critical for Histogenics as we prepare for our top-line data, potential BLA submission and FDA review of NeoCart," stated Adam Gridley, President and Chief Executive Officer of Histogenics. "We are pleased to have Lynne join us at this exciting time to educate our customers and patients about the benefits of our novel restorative cell therapy platform through training, medical education and collaboration with our future commercial team. In addition, she will be working closely with our team to help drive additional product development initiatives, such as future trials in the U.S. and internationally."

Dr. Kelley is a board certified general and vascular surgeon having received her medical degree from Dartmouth Medical School and completed her Residency in General Surgery at Dartmouth Hitchcock Medical Center. During her training she was awarded an NIH-sponsored basic science research grant at Harvard Medical School. She completed a Fellowship in Vascular Surgery at Harvard Medical School, Massachusetts General Hospital and was awarded the Marco Polo Fellowship providing advance training in Endovascular Surgery at the University Paris Hospital, Henri Mondor. Dr. Kelley also received a B.A. in Biology from Boston University. Prior to Histogenics, Dr. Kelley held various medical affairs roles within the industry including: Chief Medical Officer at Senseonics, World Wide Vice President of Medical Affairs at Becton Dickinson & Company Medical Surgical Systems Division, Vice President and Medical Director at Kimberly Clark, and Medical Director at Boston Scientific Corporation’s (Boston Scientific) Peripheral Interventions and Vascular Surgery division. Prior to her work at Boston Scientific, Dr. Kelley was an assistant professor of vascular surgery and radiology at Yale University.

"I am thrilled to join the talented, cutting edge team at Histogenics. The potential of NeoCart in restoring function and thus improving the lives of patients with debilitating joint pain is extraordinary," shared Dr. Kelley. "I look forward to collaborating with the physician community globally to bring this exciting therapy to our patients."

In connection with the hiring of Dr. Kelley, the Compensation Committee of Histogenics’ Board of Directors approved a grant to Dr. Kelley of a stock option to purchase 200,000 shares of Histogenics’ common stock. The option was granted pursuant to the Nasdaq inducement grant exception as a component of Dr. Kelley’s employment compensation, and was granted as an inducement material to her acceptance of employment with Histogenics in accordance with Nasdaq Listing Rule 5635(c)(4). The option will have an exercise price equal to the closing price of Histogenics’ common stock on July 31, 2018. The option has a ten year term and vests with respect to 25% of the shares of common stock underlying the option on the one year anniversary of Dr. Kelley’s first day of employment with Histogenics and with respect to the remaining shares in equal monthly installments over the following 36 months, subject to Dr. Kelley’s continued service with Histogenics through the applicable vesting dates.

Corvus Pharmaceuticals to Present at 2018 Wedbush PacGrow Healthcare Conference

On July 31, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported that the company will present at the 2018 Wedbush PacGrow Healthcare Conference in New York (Press release, Corvus Pharmaceuticals, JUL 31, 2018, View Source;p=RssLanding&cat=news&id=2361086 [SID1234528636]). The presentation is scheduled for Wednesday, August 15, at 8:35 a.m. Eastern Time.

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A webcast of the presentation will be available live and for 90 days following the event. The webcast may be accessed via the conference website and from the investor relations section of the Corvus website.

Atara Biotherapeutics to Participate in the Canaccord Genuity 38th Annual Growth Conference

On July 31, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Christopher Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will participate in a panel discussion at the Canaccord Genuity 38th Annual Growth Conference on Thursday, August 9, 2018 at 12:00 p.m. EDT (Press release, Atara Biotherapeutics, JUL 31, 2018, View Source [SID1234528633]). The conference will be held at the InterContinental Boston Hotel in Boston, MA.

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A live audio webcast of the panel discussion will be available by visiting the Investors section of the Atara website. An archived replay of the webcast will be available on the Company’s website for 14 days following the panel discussion.

CANBRIDGE LIFE SCIENCES APPOINTS CHIEF MEDICAL OFFICER

On July 31, 2018 CANbridge Life Sciences, a biopharmaceutical company developing Western drug candidates in China and North Asia, reported that it strengthened the executive management team with the appointment of May Orfali, MD, as Chief Medical Officer, on July 23, 2018 (Press release, CANbridge Life Sciences, JUL 31, 2018, View Source [SID1234528470]). Dr. Orfali replaced Dr. Mark Goldberg, who was acting as interim Chief Medical Officer. She is based in Cambridge, MA.

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Dr. Orfali has a deep and extensive background in clinical drug development programs that spans two decades in multiple therapeutic areas, with a focus on rare diseases, oncology, hematology, infectious disease and women’s health. Most recently, she was Executive Director, Global Product Development, Pfizer, Inc., USA, where she was responsible for patient-focused drug development across multiple rare disease assets in hematology, sickle cell disease, hemophilia, endocrinology, gene therapy and TTR-amyloidosis. Prior to that role, Dr. Orfali was Senior Director and Global Medical Lead/Medicines Development Group, Specialty Care Business Unit, Pfizer, where she was responsible for developing rare disease drug development strategy, including gene therapy; oversaw global drug development in TTR-amyloidosis, and was Global Medical Lead for hematology, specifically in hemophilia A and B, across North America, Europe and Asia, including Japan and China. Prior to her time at Pfizer, Dr. Orfali held several clinical leadership positions, including Senior Director, Global Medical Monitor, Oncology at Wyeth Pharmaceutical Company, USA; VP Clinical Development and Medical Affairs at Artisan Pharma, Inc., USA; Vice President, Clinical Research and Medical Affairs, Aeris Therapeutics, USA; Medical Director, CDMA, Cubist Pharmaceuticals and Medical Director, Women’s Health Group at Boston Scientific Corporation.

Dr. Orfali holds a medical degree from the University of Baghdad, Baghdad, Iraq, and a Pharmaceutical Masters of Business Administration from Cambridge University, Cambridge, England. She was a practicing physician, specialized in CNS Oncology Clinical Research at Dana-Farber Cancer Institute, in Boston, MA and completed her Fellowship in Pediatric Oncology/Hematology at Massachusetts General Hospital and Children’s Hospital, Boston, MA.

"We are delighted that Dr. Orfali has chosen to join CANbridge as we become a fully-commercial biopharmaceutical company with a robust clinical trial program and pipeline," said James Xue, PhD, Chairman and CEO, CANbridge Life Sciences. "Her broad international experience, and proven track record of clinical trial success in multiple indications, will be key as CANbridge continues to advance our world-class programs in oncology and orphan-designated diseases, particularly in those that are severely underserved in China and Asia. We would also like to thank Dr. Mark Goldberg for serving as our interim Chief Medical Officer. He’s played an instrumental role in CANbridge’s current success and will continue to work with us in an advisory capacity."

Fresenius Medical Care continues to grow in the second quarter and confirms outlook for 2018

Healthy organic growth across the board, North American Products business continues strong growth (Press release, Fresenius, JUL 31, 2018, View Source [SID1234528443])

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Underlying Care Coordination margin improved

Results continue to be impacted by strong currency headwinds

Calcimimetics continue to evolve

Divestiture of Sound Inpatient Physicians successfully closed

NxStage acquisition expected to close in the second half of 2018

Rice Powell, Chief Executive Officer of Fresenius Medical Care, stated: "In the second quarter, we have seen solid growth resulting in a strong net income increase of 22 percent at constant currency – excluding the positive impact of the successful and efficient closing of the Sound Inpatient Physicians divestment. On the back of the strong development of our Products business and continued growth of our Services business, we expect growth to further accelerate in the second half of 2018."

Strong Products growth
Revenue in the second quarter of 2018 was again significantly impacted by foreign currency effects, resulting in a 2% increase at constant currency to EUR 4,214 million (-6% at current rates). Adjusting the second quarter of 2017 for the impact from the IFRS 15 implementation, revenue in the second quarter of 2018 was up by 5% at constant currency. Health Care Services revenue increased by 1% at constant currency to EUR 3,385 million, driven by growth in same market treatments and contributions from acquisitions, partially offset by the effects from the implementation of IFRS 15. Excluding the negative effects from the implementation of IFRS 15 Health Care Service revenue increased by 4% at constant currency. Health Care Products revenue grew by 6% at constant currency to EUR 829 million. The increase was driven by higher sales of hemodialysis products and renal pharmaceuticals. Organic growth for Health Care Services was 3% and for Health Care Products 6%. Dialysis treatments increased by 3%, mainly as a result of growth in same-market treatments.

In the first half of 2018, revenue was stable at constant currency with EUR 8,189 million (-9% at current rates). Excluding the effect from the implementation of IFRS 15 revenue was up by 3% at constant currency. Health Care Services revenue decreased by 1% at constant currency (-11% at current rates) based on a strong comparable first half of 2017 and unfavourably affected by the implementation of IFRS 15 and the VA Agreement. Health Care Products revenue increased by 6% at constant currency (flat at current rates).

Significant contribution from divestitures of Care Coordination activities
Total operating income (EBIT) reached EUR 1,401 million, an increase of 162% at constant currency (+140% at current rates) in the second quarter of 2018. The strongest contributor was the gain related to the divestitures of Care Coordination activities. The significant contribution of EUR 833 million also includes the positive effect of gains from currency translation adjustments. Adjusting for the gain as well as the prior year impact from the VA Agreement, EBIT grew by 2% at constant currency (-4% at current rates) with an EBIT margin of 13.5%.

In the first half of 2018, EBIT increased by 68% at constant currency to EUR 1,898 million (+54% at current rates). Adjusted for the effects described above, EBIT increased by 3% at constant currency (-6% at current rates) and the EBIT margin was 13.2%.

Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA was exceptionally strong in the second quarter of 2018 with EUR 994 million (+270% at current rates), mainly driven by the gain related to the divestitures of Care Coordination activities. Excluding the gain related to the divestitures of Care Coordination activities, the increase in net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA was 22% at constant currency (+15% at current rates). Further adjusting for the prior year impact from the VA Agreement and the positive effect from the U.S. Tax Reform, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA grew by 6% on a constant currency basis to EUR 273 million (flat at current rates). Based on the number of approximately 306.4 million shares (weighted average number of shares outstanding), basic earnings per share (EPS) amounted to EUR 3.24 (+270% at current rates). On a comparable basis the company generated an EPS of EUR 1.00, up by 22% at constant currency and 15% at current rates. On an adjusted basis EPS increased by 6% to EUR 0.89 at constant currency (flat at current rates).

For the first half of 2018, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA increased by 141% at constant currency (+121% at current rates) to EUR 1,273 million, mainly driven by the gain related to the divestitures of Care Coordination activities. Adjusted for this effect, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA reached EUR 599 million, an increase of 13% at constant currency (+4% at current rates). Further adjusting for the prior year impact from the VA Agreement and the positive effect from the U.S. Tax Reform, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA reached EUR 517 million in the first half of 2018, an increase of 7% at constant currency (-1% at current rates).

Organic growth across all Reporting Segments
North America revenue, which represents 71% of total revenue in the second quarter of 2018, was stable at constant currency and reached EUR 2,971 million (-8% at current rates). Excluding the effect from the implementation of IFRS 15 revenue was up by 4% at constant currency. Organic growth was 3%.

Dialysis Care revenue increased by 4% to EUR 2,232 million at constant currency (-4% at current rates). The growth at constant currency was mainly driven by an increase in organic revenue per treatment, same market treatment growth and contributions from acquisitions, to some extent diluted by the implementation of IFRS 15 and the VA Agreement in the prior year. Adjusted for the implementation of IFRS 15, Dialysis Care revenue increased by 7% at constant currency. Organic revenue per treatment increased by 4%, same-market treatments grew by 2% and acquisitions contributed 1%. At constant currency, Care Coordination revenue decreased by 18% (-24% at current rates), driven by the shift of calcimimetic drugs into the clinical environment and the implementation of IFRS 15, partially offset by improved performance in certain services prior to divestiture. Excluding the effect from the implementation of IFRS 15 Care Coordination revenue decreased by 10% at constant currency.

In the U.S., the average revenue per treatment, adjusted for the implementation of IFRS 15 and excluding the 2017 impact of the VA Agreement, increased by USD 13 from USD 341 to USD 354. The increase was mainly driven by the introduction of calcimimetic drugs in the clinical environment, which is still evolving. The increase was partially offset by lower revenue from commercial payors, as expected, and higher implicit price concessions (IFRS 15).

Cost per treatment in the U.S., adjusted for the implementation of IFRS 15, increased by USD 14 from USD 272 to USD 286. This development was largely a result of the introduction of calcimimetic drugs in the clinical environment as well as increased property and other occupancy related costs, partially offset by lower costs for health care supplies.
At constant currency, Health Care Products revenue showed a strong increase of 10% to EUR 210 million due to higher sales of renal pharmaceuticals, machines and hemodialysis concentrates. Lower external sales in peritoneal dialysis products affected the overall positive development.

Total operating income for the North America segment was EUR 1,286 million in the second quarter of 2018, an increase of 200% at constant currency (+174% at current rates). This increase was mainly driven by the gain related to divestitures of Care Coordination activities. Adjusted for this impact and the 2017 effects from the VA Agreement, operating income (EBIT) was EUR 453 million compared to EUR 471 million in the second quarter of 2017. The adjusted operating income margin was stable at 15.2%.

For the first half of 2018, North America revenue decreased by 3% at constant currency to EUR 5,746 million (-13% at current rates). Adjusted for the implementation of IFRS 15 (EUR 270 million), revenue increased by 1% at constant currency (-9% at current rates). Mainly driven by the gain related to divestitures of Care Coordination activities operating income went up by 83% at constant currency (+66% at current rates) to EUR 1,648 million in the first half of 2018.

As of the end of June 2018, the company was treating 199,527 patients (+3%) at its 2,439 clinics (+4%) in North America. Dialysis treatments increased by 3%.

EMEA revenue increased by 5% at constant currency (+2% at current rates) to EUR 652 million in the second quarter of 2018, mainly driven by the positive development in Health Care Services revenue and Health Care Products revenue, which increased by 5% and 4%, respectively, at constant currency. The increase in Health Care Services revenue was driven by same-market treatment growth and acquisitions. Dialysis Products revenue grew by 5% at constant currency (+2% at current rates) to EUR 319 million, due to higher sales of dialyzers, machines, bloodlines, products for acute care treatments and renal pharmaceuticals.

Non-dialysis Products revenue decreased by 8% at constant currency (-8 % at current rates) to EUR 18 million, primarily due to slightly lower sales volumes.

Operating income was EUR 105 million in the second quarter of 2018. The operating income margin decreased from 17.6% to 16.1%, mainly due to unfavorable impacts from lower income from equity method investees, higher personnel costs in certain countries and an increase in bad debt expenses.

For the first half of 2018, EMEA revenue increased by 5% at constant currency to EUR 1,288 million (+3% at current rates), while operating income of EUR 214 million was 5% below last year´s level at constant currency (-6% at current rates).

As of the end of June 2018, the company had 63,589 patients (+4%) being treated at 758 clinics (+4%) in the EMEA region. Dialysis treatments increased by 4%.

Asia-Pacific revenue grew by 7% at constant currency to EUR 422 million (+1% at current rates) in the second quarter of 2018. Health Care Services revenue in the region increased by 7% at constant currency to EUR 191 million (flat at current rates). Care Coordination activities contributed EUR 49 million (+32% at constant currency, +24% at current rates) to Health Care Services revenue. This strong Care Coordination growth in Asia Pacific was mainly related to acquisitions and a strong organic revenue growth. Health Care Products showed again a solid business performance, growing 6% at constant currency to revenues of EUR 231 million (+2% at current rates). This growth was mainly driven by higher sales of hemodialysis products, partially offset by lower sales of products for acute care treatments. Operating income reached the same level as the previous year’s quarter (EUR 78 million). The operating income margin decreased slightly to 18.4%, driven by unfavorable foreign currency impacts and increased costs for the business growth, mainly in China.

For the first half of 2018, Asia-Pacific revenue increased by 10% at constant currency to EUR 814 million. Operating income decreased by 1% at constant currency with EUR 152 million (-5% at current rates).

As of the end of June 2018, the company had 30,578 patients (+2%) being treated at 385 clinics in Asia-Pacific. Dialysis treatments increased by 2%.

Latin America delivered revenue of EUR 164 million in the second quarter of 2018, an improvement of 11% at constant currency (-10% at current rates). This growth was mainly driven by a strong growth in Health Care Services (+15% at constant currency) due to an increase in organic revenue per treatment, acquisitions and growth in same market treatments. Health Care Products revenue in Latin America increased by 2% at constant currency to EUR 46 million, due to higher sales of machines and peritoneal dialysis products and negatively affected by lower sales of dialyzers. With an operating income of EUR 11 million the segment generated an operating income on previous year’s level. The operating income margin remained at 6.8%.

For the first half of 2018, Latin America revenue increased by 14% at constant currency to EUR 334 million (-7% at current rates). Operating income was EUR 25 million, an increase of 5% at constant currency (-6% at current rates).

As of the end of June 2018, the company was treating 31,494 patients (+4%) at 233 clinics in Latin America (+1%). Dialysis treatments increased by 4%.

Net interest expense was EUR 84 million compared to EUR 95 million in the second quarter of 2017, a decrease of 6% at constant currency (-11% at current rates). The decrease was driven by a replacement of high interest-bearing senior notes by debt instruments at lower rates as well as a decreased debt level. Income tax expense was EUR 262 million for the second quarter of 2018, which translates into an effective tax rate of 19.9%, compared to last year’s Q2 with a tax rate of 30.8%. The strong reduction was largely driven by the U.S. Tax Reform and the gain related to divestitures of Care Coordination activities.

Strong cash flow generation
In the second quarter of 2018, the company generated EUR 656 million of operating cash flow, compared to EUR 883 million provided by operating activities in last year’s second quarter. This decrease was mainly driven by increased accounts receivable related to the addition of calcimimetics into the Medicare ESRD payment bundle and unfavorable foreign currency effects. The number of days sales outstanding (DSOs) decreased sequentially by three days compared with Q1 2018 to reach 82 days. Free cash flow (Net cash used in operating activities, after capital expenditures, before acquisitions and investments) amounted to EUR 429 million for the three months ended June 30, 2018 compared to EUR 690 million for the same period of 2017. Free cash flow in percent of revenue was 10.2% and 15.4% for the three months ended June 2018 and 2017, respectively.

Sound Physicians divestiture successfully closed
On June 28, Fresenius Medical Care announced the closing of the divestiture of Sound Inpatient Physicians Holdings, LLC to an investment consortium led by Summit Partners. In the second half of 2017, the Sound Physicians business generated revenue of EUR 559 million and a net income of EUR 38 million. The 2017 basis has been adjusted accordingly for measuring the performance against the 2018 outlook.

Closing of NxStage Medical acquisition expected for second half 2018
In August 2017, Fresenius Medical Care signed an agreement with NxStage Medical, a U.S.-based medical technology and services company, to acquire all outstanding shares of NxStage Medical through a merger. The merger, which has been approved by NxStage’s board, NxStage stockholders and authorities in Germany, is still subject to regulatory approval by the Federal Trade Commission under the Hart-Scott-Rodino Act. Fresenius Medical Care has exercised its contractual right under the merger agreement to extend the original closing deadline by 90 days from August 7, 2018 to November 5, 2018. Fresenius Medical Care expects to close the transaction in 2018.

Employees
As of June 30, 2018, Fresenius Medical Care had 111,263 employees (full-time equivalents) worldwide, compared to 112,163 employees at the end of June 2017. This decrease was mainly attributable to divestitures of certain Care Coordination activities.

Outlook 2018
The company expects revenue1 growth between 5% and 7% at constant currency. Net income on a comparable basis2 is expected to increase by 13% to 15% at constant currency and on an adjusted basis2,3 to increase by 7% to 9% at constant currency.

The targets exclude the effect from the planned acquisition of NxStage Medical and the gain (loss) related to divestitures of Care Coordination activities.

1 2017 adjusted for the effect of IFRS 15 implementation and the contribution of Sound Physicians in H2 2017
2 Attributable to shareholders of Fresenius Medical Care AG & Co. KGaA, adjusted for the contribution from Sound Physicians in H2 2017
3 VA Agreement, Natural Disaster Costs, FCPA related charge, U.S. Tax Reform

Conference call
Fresenius Medical Care will host a conference call to discuss the results of the second quarter today at 3:30 p.m. CEDT / 9:30 a.m. EDT. Details will be available on the company’s website www.freseniusmedicalcare.com in the "Investors/Events" section. A replay will be available shortly after the call.