On August 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 June 30, 2018 (Press release, MacroGenics, AUG 7, 2018, View Source [SID1234528763]).
"MacroGenics continues to advance its portfolio of oncology product candidates toward multiple data read-outs," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We expect to complete enrollment of the SOPHIA Phase 3 metastatic breast cancer study of margetuximab in the next few months and be able to disclose top-line results in the first quarter of 2019. Also in early 2019, we expect to provide an update on the combination study of margetuximab with an anti-PD-1 agent in the treatment of gastric cancer patients in a Phase 2 study. In addition, we will provide updates later this year on both the enoblituzumab plus anti-PD-1 combination study, as well as the flotetuzumab monotherapy dose expansion study in patients with relapsed/refractory acute myeloid leukemia (AML). Finally, we recently submitted an investigational new drug (IND) application for our first antibody-drug conjugate – MGC018, an anti-B7-H3 ADC – and anticipate submitting an IND for MGD019 (PD-1 x CTLA-4 DART molecule) by year-end."
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:

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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. MacroGenics remains on track to complete enrollment of the study in the next few months, with anticipated disclosure of topline PFS data in the first quarter of 2019.

Phase 2 Gastric Cancer Study. At the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting in June, MacroGenics presented updated interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with HER2-positive gastroesophageal adenocarcinoma. This chemotherapy-free combination, designed to coordinately engage innate and adaptive immunity, demonstrated that margetuximab plus an anti-PD-1 antibody may have enhanced antitumor activity in patients with advanced gastric cancer. The Company expects to complete enrollment of 25 additional gastric cancer patients in the next few months and present data in the first quarter of 2019.

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 and plans to present updated clinical data and disclose further development plans in late 2018. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

Combination Study with MGA012. 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 commence enrollment of a combination study

Exhibit 99.1

with MGA012, an anti-PD-1 mAb also known as INCMGA0012, later this year.
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:

MGA012. This humanized, proprietary anti-PD-1 mAb is being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. MGA012 was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the rights to develop MGA012 in combination with its pipeline assets, and has already initiated clinical combination studies with two separate DART molecules. In June 2018, Incyte announced its intention to pursue monotherapy development of MGA012 in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer through registration-directed studies, with data anticipated in 2020-2021.

MGD013. This first-in-class DART molecule provides 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 study. MacroGenics expects to establish the dose and schedule for MGD013 administration as well as initiate dose expansion cohorts by year end 2018.

MGD019. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4 on T cells. The Company anticipates submitting the IND application for MGD019 by year end 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 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 as well as disclose further development plans in the fourth quarter of 2018.

Orlotamab (formerly known as MGD009): This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study. The Company recently established the dose and schedule for orlotamab administration and initiated monotherapy dose expansion cohorts in six different tumor types. In addition, a combination study of orlotamab and MGA012 was initiated in the first quarter of 2018 and is ongoing.

MGC018: The Company has submitted an IND for this anti-B7-H3 ADC and anticipates initiation of a Phase 1 study in the coming months. This first-in-man study is designed to study MGC018 both as monotherapy and in combination with MGA012 in patients with solid tumors.

Second Quarter 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2018, were $300.9 million, compared to $305.1 million as of December 31, 2017.

Exhibit 99.1

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $18.8 million for the quarter ended June 30, 2018, compared to $1.7 million for the quarter ended June 30, 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 $52.0 million for the quarter ended June 30, 2018, compared to $34.5 million for the quarter ended June 30, 2017. This increase was primarily due to the continued enrollment in the Company’s two margetuximab studies, flotetuzumab study and increased headcount to support expanded manufacturing and development activities.

G&A Expenses: General and administrative expenses were $11.1 million for the quarter ended June 30, 2018, compared to $8.4 million for the quarter ended June 30, 2017. This increase was primarily due to consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system and increased patent expenses.

Net Loss: Net loss was $43.2 million for the quarter ended June 30, 2018, compared to net loss of $40.7 million for the quarter ended June 30, 2017.

Shares Outstanding: Shares outstanding as of June 30, 2018 were 42,229,011.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended June 30, 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: 9259899.

On August 7, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported key leadership transitions as part of its evolution into a commercial-stage oncology company (Press release, Eleven Biotherapeutics, AUG 7, 2018, View Source [SID1234528946]). Thomas Cannell, DVM has been appointed chief executive officer and a member of the board of directors, bringing with him a wealth of leadership experience in building and overseeing strategic operations and global pharmaceutical commercialization for life science companies. Stephen Hurly left his employment with Sesen Bio effective August 7, 2018.

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"Over the last two years, Sesen Bio has undergone a unique evolution as a company. Following the acquisition of Viventia and the resulting transition from an ophthalmology organization to an oncology company, we have been wholly focused on developing Vicinium for high-grade non-muscle invasive bladder cancer," said Wendy Dixon, Ph.D., chair of Sesen Bio’s board of directors. "We are grateful to Steve for his many significant contributions in advancing Sesen Bio to where it is today, and we wish him all the best in his future endeavors. As we transition further as a company, Tom will be an exceptional strategic leader bringing deep experience in drug development and commercialization to drive Vicinium, our pipeline and the company through this important next chapter."

Thomas Cannell most recently served as chief operating officer and president of global commercial products at Orexigen Therapeutics, Inc., where he led the successful commercialization and profitability of Contrave. Prior to Orexigen, Dr. Cannell spent 27 years with Merck & Co., Inc., where he held senior leadership positions in global commercialization, consumer marketing, and sales operations and management for both development-stage programs and approved marketed products. While with Merck, he served as president of Merck Canada and head of marketing and strategy for Merck Sharp & Dohme Corp., Japan, a subsidiary of Merck & Co., where he was responsible for setting up a long-standing strategic process and plan, managed a multi-billion-dollar product portfolio and oversaw thousands of employees. In addition, he designed and successfully piloted an innovative, customer-centric commercial model for Merck’s U.S. business. Dr. Cannell received his DVM degree from Washington State University.

"My enthusiasm for joining Sesen Bio is based on the novel mechanism of Vicinium, its potential as a monotherapy and combination agent, particularly with checkpoint inhibitors, and the range of therapeutic opportunities with our novel fusion proteins," stated Dr. Cannell. "Over the next several months, we will be focused on several strategic objectives across our pipeline. These include: completing the Phase 3 registration trial for Vicinium with 12-month data expected by mid-2019; engaging with regulatory authorities to prepare for our first BLA submission; initiating the appropriate pre-commercial activities to support a potential future product approval and launch; and exploring new therapeutic opportunities in additional indications. I am excited to join the company at this pivotal time and believe strongly in our ability to execute these strategic priorities to make a meaningful difference in the lives of patients."

Sesen Bio also announced today that Abbie Celniker, Ph.D. and Paul Chaney have stepped down from the company’s board of directors, effective August 7, 2018. Dr. Celniker, who served on the board of directors since the company’s founding by Third Rock Ventures in 2011, is focusing on her partner role at Third Rock Ventures and early-stage portfolio-building efforts. Mr. Chaney joined the company’s board in 2014 as a leader in developing innovative ophthalmic therapeutics and is leaving to continue his efforts in that area of drug development.

"I am very proud of the progress and many milestones that the Sesen Bio team has achieved, and it has been a pleasure to serve on the board with this outstanding group of industry leaders," said Dr. Celniker. "The company is uniquely positioned with a Phase 3 trial that is well underway, established clinical data, a lead product candidate with a pipeline of opportunities and a strong balance sheet to fund its growing organization. I look forward to watching Sesen Bio’s continued success as a supportive investor with Third Rock Ventures."

In connection with the appointment of Dr. Cannell, Sesen Bio entered into an employment agreement with Dr. Cannell that, among other things, provides for the grant of a non-statutory stock option outside of the company’s 2014 Stock Incentive Plan as an inducement material to Dr. Cannell’s entering into employment with Sesen Bio in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The stock option to purchase 1,350,000 shares of the company’s common stock is being granted effective as of August 7, 2018. The stock option grant was approved by the independent compensation committee of the board of directors in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The stock option will have an exercise price per share equal to the closing price per share of Sesen Bio’s common stock on The Nasdaq Global Market on August 7, 2018. The stock option will have a ten-year term and will vest over a four-year period, with 25 percent of the shares underlying the stock option award vesting on the first anniversary of the date of grant and an additional 6.25 percent of the shares underlying the stock option vesting at the end of each successive three-month period following the one-year anniversary of the date of grant of the stock option, subject to Dr. Cannell’s continued service with the company through the applicable vesting dates.

On August 7, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the second quarter ended June 30, 2018 and recent company developments (Press release, Manhattan Pharmaceuticals, AUG 7, 2018, View Source [SID1234528482]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased with the progress made in the first half of 2018 and believe we have many value creating milestones achievable in the near future. This morning’s announcement of complete target enrollment in the ULTIMATE I & II Phase 3 trials in MS well ahead of our projections, similar to the rapid enrollment we had seen in our UNITY-CLL Phase 3 trial, reinforces our belief in the great need for our product candidates." Mr. Weiss continued, "We believe TG has never been better positioned for success and look forward to an impactful remainder of the year, and importantly the announcement of topline overall response rate data from the UNITY-CLL Phase 3 trial before the end of the summer."

Recent Developments and Highlights

ULTIMATE I & II: Completed target enrollment into the ULTIMATE I & II Phase 3 trials in Multiple Sclerosis (MS).
Anti-CD47/CD19 License: Entered into an exclusive global license agreement with Novimmune SA to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701).
Ublituximab Data in Multiple Sclerosis: Presented updated clinical data from the Phase 2 trial of ublituximab in RMS at the 4th Congress of European Academy of Neurology Meeting.
TG-1701 Preclinical Data: Presented the first preclinical data presentation of TG-1701, the Company’s orally available and covalently-bound BTK inhibitor, at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).
Umbralisib Data in CLL Patients Intolerant to Prior BTK/PI3K: Presented clinical data from the Phase 2 trial of umbralisib in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and at the 23rd Congress of the EHA (Free EHA Whitepaper).
Umbralisib plus Ruxolitinib Data in Patients with Myelofibrosis: Presented updated clinical data from its ongoing Phase I study evaluating umbralisib with ruxolitinib, the JAK 1/2 inhibitor, in ruxolitinib experienced patients with myelofibrosis at the 23rd Annual EHA (Free EHA Whitepaper) Congress.
Umbralisib Safety Data: Presented an integrated analysis of long term safety data of umbralisib, either dosed as a single agent and in combination, in patients with relapsed or refractory lymphoid malignancies at the 23rd Annual EHA (Free EHA Whitepaper) Congress.
Chief Commercial Officer: Announced the hiring of Adam Waldman, former Celgene executive, as our Chief Commercial Officer.

Key Remaining 2018 Milestones

Present top-line overall response rate results from our UNITY-CLL Phase 3 trial in front line and relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
Prepare and potentially file the Company’s first BLA and/or NDA.
Complete enrollment in the current arms of the UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.
Present updated clinical data from ongoing oncology trials and final results from the Phase 2 trial of ublituximab in Multiple Sclerosis (MS) at major medical meetings during 2018.

Financial Results for the Second Quarter 2018

Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $126.3 million as of June 30, 2018.

R&D Expenses: Research and development (R&D) expenses were $38.7 million and $73.7 million for the three and six months ended June 30, 2018, respectively, compared to $26.7 million and $49.4 million for the three and six months ended June 30, 2017. The increase in R&D expense is primarily attributable to an increase in clinical trial expenses of $10.0 million and $15.7 million, respectively during the three and six months ended June 30, 2018, as compared to prior periods. In addition, included in R&D expenses for the three and six months ended June 30, 2018 are $1.8 million and $11.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. Also included in R&D expense for the six months ended June 30, 2018 was $4 million ($3 million of which was recorded in the three months ended June 30, 2018) of non-cash stock expense recorded in conjunction with the licenses to the BTK and CD47/CD19 programs.

G&A Expenses: General and administrative (G&A) expenses were $5.7 million and $12.3 million for the three and six months ended June 30, 2018, respectively, as compared to $1.8 million and $6.8 million for the three and six months ended June 30, 2017. The increase in G&A expenses for the three and six months ended June 30, 2018 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during the three and six months ended June 30, 2018.

Net Loss: Net loss was $44.1 million and $85.7 million for the three and six months ended June 30, 2018, respectively, compared to a net loss of $28.4 million and $56.1 million for the three and six months ended June 30, 2017, respectively. Excluding non-cash items, the net loss for the three and six months ended June 30, 2018 was approximately $36.9 million and $70.1 million.

Financial Guidance: Net cash utilized for operating activities during the six months ended 2018 was approximately $62.2 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of June 30, 2018 will be sufficient to fund the Company’s planned operations into the second half of 2019.

Conference Call Information

The Company will host an investor conference call today, August 7, 2018, at 4:30pm ET, to discuss the Company’s second quarter 2018 financial results and provide a business outlook for the remainder of 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter 2018 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

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On August 7, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported financial results and recent highlights for the second quarter ended June 30 (Press release, Halozyme, AUG 7, 2018, View Source [SID1234528498]).

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"At the beginning of 2018 we projected the potential for approximately $1 billion in ENHANZE royalty revenue in 2027 resulting from continued growth of our 3 currently marketed products and the successful development, approval and launch of 7 additional products," said Dr. Helen Torley, president and chief executive officer. "I am delighted to report strong progress in both the marketed products and the development products, with all 7 new products expected to be in the clinic by the end of this year.

"In tandem, we continue to execute well in our HALO-301 study, with enrollment tracking to expectations and continued enthusiasm and support from key opinion leaders and investigators. We also look forward to advancing our pan-tumor plan by sharing data from our collaboration study with Eisai in breast cancer patients at the European Society for Medical Oncology congress in October."

Second Quarter 2018 and Recent Highlights include:

U.S. Food and Drug Administration (FDA) accepting Roche/Genentech’s Biologics License Application (BLA) for a subcutaneous formulation of Herceptin in combination with Halozyme’s ENHANZE technology in its FDA-approved breast cancer indications. Roche reported total 2017 sales of Herceptin in the United States of 2.7 billion CHF.
Roche initiating a Phase 3 study of a fixed-dose combination of subcutaneous pertuzumab (Perjeta ) and subcutaneous trastuzumab (Herceptin) using Halozyme’s ENHANZE technology in combination with chemotherapy in patients with HER2-positive early breast cancer. This follows supportive Phase 1 study results for the same combination presented at the 2017 San Antonio Breast Cancer Symposium.
Collaboration partner Bristol-Myers Squibb progressing toward three Phase 1 studies with ENHANZE. Studies include evaluation of an investigational anti-CD-73 antibody, an investigational product against an undisclosed target and the PD-1 targeted asset, Opdivo (nivolumab), all planned for initiation in Q3.
Janssen continuing in multiple ongoing trials of a subcutaneous formulation of DARZALEX (daratumumab) in support of plans for commercialization. Halozyme’s ENHANZE technology has the potential to enable a 15-ml injection to be delivered in five minutes or less. Ongoing trials in patients with Multiple Myeloma, Amyloidosis and Smoldering Myeloma include four Phase 3 studies and two earlier stage studies.
Alexion continuing to progress toward initiating a Phase 1 study of ALXN1210 with ENHANZE, planned for later this year.
Acceptance of data from the Phase 1b study of PEGPH20 and HALAVEN (eribulin) in patients with HER2-negative, high-hyaluronan metastatic breast cancer for presentation at the 2018 European Society for Medical Oncology Congress.
U.S. Patent and Trademark Office granting Halozyme a patent for the combination of PEGPH20, ABRAXANE (nab-paclitaxel) and gemcitabine for the potential treatment of metastatic pancreas cancer, with an expiration date of March 2033. The same application is pending or has been issued in multiple countries outside of the United States.
Continued progress screening and enrolling patients in the HALO-301 study of PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in first-line metastatic pancreas cancer patients with high levels of tumor hyaluronan (HA-High). An interim analysis will be conducted for the first primary endpoint of Progression Free Survival (PFS) when the target number of events has been reached, which the company projects will occur between December 2018 and February 2019.
Second Quarter 2018 Financial Highlights

Revenue for the second quarter was $35.2 million compared to $33.8 million for the second quarter of 2017. The year-over-year increase was driven by $10 million in milestone revenue and 36 percent growth in royalties on a reported basis from partner sales of Herceptin (trastuzumab) SC, MabThera (rituximab) SC, RITUXAN HYCELA and HYQVIA (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), offset by the expected decrease in bulk rHuPH20 sales to partners and research and development reimbursements. Revenue for the second quarter included $20 million in royalties and $3.8 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Research and development expenses for the second quarter were $40.1 million, compared to $38.3 million for the second quarter of 2017.
Selling, general and administrative expenses for the second quarter were $14.4 million, compared to $13.1 million for the second quarter of 2017.
Net loss for the second quarter was $22.9 million, or $0.16 per share, compared to net loss in the second quarter of 2017 of $30.8 million, or $0.23 per share.
Cash, cash equivalents and marketable securities were $398.9 million at June 30, 2018, compared to $469.2 million at December 31, 2017.
Financial Outlook for 2018

For the full year 2018, the company updated its prior guidance ranges for net revenue and year-end cash, now expecting:

Net revenue increasing from the prior range of $115 million to $125 million to $125 million to $135 million, driven by milestones from ENHANZE Phase 1 study initiations;
Operating expenses to continue to be in the range of $230 million to $240 million;
Operating cash burn to continue to be in the range of $75 million to $85 million; and
Year-end cash balance increasing from the prior range of $305 million to $315 million to $310 million to $320 million, driven by ENHANZE milestones partially offset by a modest build in rHuPH20 inventory in anticipation of future partner demand.
Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the second quarter of 2018 today, Tuesday, August 7 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording made available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 40189200.

On August 7, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its second-quarter 2018 financial results (Press release, Valeant, AUG 7, 2018, View Source [SID1234528518]).

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"For a second consecutive quarter, the Company delivered overall organic growth2, driven by solid results in our Salix and Bausch + Lomb/International segments, which together represented approximately 78% of our business in the quarter," said Joseph C. Papa, chairman and CEO, Bausch Health. "Growth in the Salix segment reflects higher sales of our promoted brands, most notably XIFAXAN and RELISTOR, while organic growth2 in the Bausch + Lomb/International segment was primarily due to volume increases and strong growth across Europe and China."

"Due to our strong results in the quarter, we are raising our full-year Adjusted EBITDA (non-GAAP) guidance range, and despite significant foreign exchange headwinds, we are maintaining our full-year revenue guidance range," continued Mr. Papa.

Company Highlights

Executing on Core Businesses and Advancing Pipeline

Completed Company’s name change to Bausch Health Companies Inc.
Realigned into four reporting segments3 (Bausch + Lomb/International, Salix, Ortho Dermatologics and Diversified Products) as part of the Company’s ongoing transformation; this provides greater clarity into the performance of each of our businesses
Reported revenue in the Bausch + Lomb/International segment decreased by 1% compared to the second quarter of 2017 primarily due to divestitures and discontinuations; revenue in this segment grew organically2 by 4% compared to the second quarter of 2017, driven primarily by volume increases and strong growth in Europe and China
Successfully launched LUMIFY, which achieved a weekly market share of 21% in the Redness Reliever category4
Launched Soothe Xtra Protection Preservative Free lubricant eye drops
Launched Ocuvite Blue Light eye vitamins, a nutritional supplement that helps protect eyes from blue light emitted from digital devices
Launched PreserVision AREDS 2 Formula Chewable eye vitamins
The U.S. Food and Drug Administration accepted the New Drug Application for loteprednol etabonate ophthalmic gel, 0.38% with a PDUFA action date of Feb. 25, 2019
Grew revenue in the Salix segment by 14% compared to the second quarter of 2017
XIFAXAN revenue increased by 26% compared to the second quarter of 2017
RELISTOR franchise revenue increased by 43% compared to the second quarter of 2017
APRISO revenue increased by 3% compared to the second quarter of 2017
UCERIS franchise revenue increased by 3% compared to the second quarter of 2017
Entered into an exclusive agreement with US WorldMeds to co-promote LUCEMYRA, the first and only non-opioid medication for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, and have now launched the product
Continued to stabilize the Ortho Dermatologics segment
Revenue in the Global Solta business increased by 14% compared to the second quarter of 2017
Addressing Debt and Extending Maturities

Refinanced Company’s credit facility
Extended the maturity date of the revolving credit facility to June 1, 2023
Replaced previous Term B loans with new Term B loans that have a maturity date of June 1, 2025
Modified facility covenants to provide the Company with enhanced operating flexibility
Lowered interest rates applicable to the credit facility
Issued $750 million aggregate principal amount of 8.500% unsecured Senior Notes due 2027
On June 1, 2018, a portion of the net proceeds from the new Term B loans and the 8.500% unsecured Senior Notes due 2027, along with cash on hand, were put on deposit with a trustee and subsequently used to redeem, on July 2, 2018, approximately $2 billion of unsecured Senior Notes, including all remaining unsecured Senior Notes due in 2020, and to pay related fees and expenses
Resolving Legal Issues

Achieved dismissals or other positive outcomes in resolving litigation, disputes and investigations in approximately 40 matters since Jan. 1, 2018
The Company continues to achieve positive resolutions in the Shower to Shower cases, with legal fees and costs being reimbursed by Johnson & Johnson
Second-Quarter 2018 Revenue Performance

Total reported revenues were $2.128 billion for the second quarter of 2018, as compared to $2.233 billion in the second quarter of 2017, a decrease of $105 million, or 5%. Excluding the impact of the 2017 divestitures and discontinuations of $183 million and the favorable impact of foreign exchange of $25 million, revenue grew organically2 by 3% compared to the second quarter of 2017, primarily driven by growth in the Salix segment and organic growth2 in the Bausch + Lomb/International segment. Organic revenue growth2 was partially offset by declines in the Ortho Dermatologics segment and lower volumes in the Diversified Products segment, attributed to the previously reported loss of exclusivity for a basket of products.

Bausch + Lomb/International segment revenues were $1.209 billion for the second quarter of 2018, as compared to $1.223 billion for the second quarter of 2017, a decrease of $14 million, or 1%. Excluding the impact of divestitures and discontinuations of $84 million, and the favorable impact of foreign exchange of $25 million, the Bausch + Lomb/International segment grew organically2 by approximately 4% compared to the second quarter of 2017. Organic growth2 in the quarter was primarily driven by volume increases.

Salix Segment

Salix segment revenues were $441 million for the second quarter of 2018, as compared to $387 million for the second quarter of 2017, an increase of $54 million, or 14%. Growth was largely driven by higher sales of XIFAXAN, RELISTOR and other promoted products across the segment.

Ortho Dermatologics Segment

Ortho Dermatologics segment revenues were $142 million for the second quarter of 2018, as compared to $162 million for the second quarter of 2017, a decrease of $20 million, or 12%. Compared to the second quarter of 2017, revenues in the Global Solta business grew by 14%.

Diversified Products Segment

Diversified Products segment revenues were $336 million for the second quarter of 2018, as compared to $461 million for the second quarter of 2017, a decrease of $125 million, or 27%. The decline was primarily driven by the impact of the 2017 divestitures and discontinuations of $97 million and by decreases attributed to the previously reported loss of exclusivity for a basket of products.

Operating Loss

Operating loss was $245 million for the second quarter of 2018, as compared to an operating income of $175 million for the second quarter of 2017, a decrease of $420 million. The decrease in operating results for the second quarter of 2018 primarily reflects an asset impairment associated with the loss of exclusivity of a certain product, an increase in amortization of intangible assets and a decrease in product contribution driven by the impact of divestitures and discontinuations.

Net Loss

Net loss for the three months ended June 30, 2018 was $873 million, as compared to net loss of $38 million for the same period in 2017, a decrease of $835 million. The decrease is primarily attributed to an increase in operating loss, as noted above, and an increase in the provision for income taxes of $343 million, which is primarily due to internal tax reorganizational efforts that the Company began in the fourth quarter of 2016 and completed in the third quarter of 2017.

Adjusted net income (non-GAAP) for the second quarter of 2018 was $327 million, as compared to $362 million for the second quarter of 2017, a decrease of 10%.

Operating Cash

The Company delivered $222 million in operating cash in the second quarter of 2018, as compared to $268 million in the second quarter of 2017, a decrease of $46 million. Cash flows in the second quarter of 2018 were negatively affected by approximately $70 million due to divestitures in 2017, $57 million of accelerated interest payments in connection with the refinancings in June 2018 and approximately $50 million in payments for legal settlements. In the second quarter of 2017, operating cash also included $190 million of net payments made in the resolution of the Salix securities class action litigation.

EPS

GAAP Earnings Per Share (EPS) Diluted for the second quarter of 2018 were $(2.49), as compared to $(0.11) for the second quarter of 2017.

Adjusted EBITDA(non-GAAP)

Adjusted EBITDA (non-GAAP) was $868 million for the second quarter of 2018, as compared to $951 million for the second quarter of 2017, a decrease of $83 million. Adjusted EBITDA (non-GAAP) in the second quarter of 2018 reflects the impact of 2017 divestitures of approximately $70 million, transactional foreign exchange and other of $51 million, the impact of the loss of exclusivity of certain products of $59 million and favorable translational foreign exchange of $10 million.

2018 Financial Outlook

Bausch Health has maintained its full-year revenue guidance range for 2018 and has raised its full-year Adjusted EBITDA (non-GAAP) guidance range for 2018:

Full-Year Revenues in the range of $8.15 – $8.35 billion
Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.20 – $3.35 billion from $3.15 – $3.30 billion
Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The guidance provided in this section represents forward-looking information, and actual results may vary materially. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

Additional Highlights

Bausch Health’s cash and cash equivalents were $838 million at June 30, 2018
The Company’s availability under the Revolving Credit Facility was approximately $725 million at June 30, 2018

Conference Call Details

Date: Tuesday, Aug. 7, 2018

Time: 8:00 a.m. EDT

Web cast: View Source

Participant Event Dial-in: (844) 428-3520 (North America)

(409) 767-8386 (International)

Participant Passcode: 1378128

Replay Dial-in: (855) 859-2056 (North America)

(404) 537-3406 (International)

Replay Passcode: 1378128 (replay available until Oct. 7, 2018)