On August 8, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the second quarter ended June 30, 2018 and provided an update on its programs (Press release, Synlogic, AUG 8, 2018, View Source [SID1234528561]).

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"Synlogic’s recent progress, including initiation of two clinical trials and multiple presentations of preclinical data, highlight the potential of Synthetic Biotic medicines across a range of diseases," said Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer and chief medical officer. "In the second half of 2018, we look to continue this momentum as we advance our clinical pipeline, with data expected from phase 1/2 clinical trials of our two lead programs, SYNB1020 in patients with hyperammonemia due to cirrhosis and SYNB1618 in healthy volunteers. In addition, we look forward to advancing our first immuno-oncology program into IND-enabling studies for the treatment of cancer."

Recent Highlights
Pipeline

Presentation of preclinical data highlighting potential of Synthetic Biotic medicines in immuno-oncology (IO) at the annual meeting of the Federation of Clinical Immunology Societies (FOCIS 2018), including the platform’s broad capabilities to generate candidates that secrete or consume immunologically relevant compounds for the potential treatment of cancer and inflammation. Data presented in two sessions demonstrate that intratumorally injected E. coli Nissle was able to colonize and persist in the tumor, and that multiple functions can be engineered into a single bacterial strain. These properties support the continued development of Synthetic Biotic immunotherapies for the treatment of solid tumors, particularly "cold" tumors that may be resistant to current immunotherapies due to their lack of infiltrating immune cells or a highly immunosuppressive tumor microenvironment. Synlogic plans to advance its first immuno-oncology program into IND-enabling studies in the fourth quarter of 2018.
Presentation of preclinical data supporting continued development of SYNB1618 for the treatment of Phenylketonuria (PKU) in a plenary session at the annual meeting of the American Society for Microbiology (ASM Microbe 2018). The data demonstrate, in a mouse model of PKU and healthy non-human primates, that orally administered SYNB1618 can result in significant decreases in blood phenylalanine levels and dose-responsive pharmacokinetics. Synlogic is currently evaluating SYNB1618 in a Phase 1/2a clinical trial for the management of PKU and expects to report interim data from healthy volunteers before the end of 2018 and full data that includes cohorts of patients with PKU in 2019.
Presentation of new preclinical data highlighting beneficial activity of SYNB1020 in animal model of liver disease at Digestive Disease Week (DDW 2018). The data demonstrate that, in addition to lowering systemic levels of ammonia, administration of SYNB1020 resulted in reduced indicators of liver damage, providing additional support for its continued development for the potential treatment of liver disease. SYNB1020 is currently being evaluated in a Phase 1b/2a clinical trial in patients with elevated ammonia due to cirrhosis, with topline data expected at the end of 2018.
Corporate

Strengthened balance sheet: As of June 30, 2018, Synlogic had cash, cash equivalents, and short-term investments of $143.2 million which includes $28.9 million in net proceeds generated by a registered direct offering completed in April 2018.
Addition to Russell 3000 Index following its annual reconstitution, providing Synlogic increased visibility and exposure to institutional investors.
Second Quarter 2018 Financial Results
For the three months ended June 30, 2018, Synlogic reported a consolidated net loss of $14.6 million, or $0.59 per share, compared to a consolidated net loss of $9.4 million, or $4.70 per share, for the corresponding period in 2017.

Research and development expenses were $10.9 million for the three months ended June 30, 2018 compared to $8.5 million for the corresponding period in 2017. The increase was primarily due to an increase in expenses associated with Synlogic’s SYNB1618 program including its ongoing Phase 1/2a clinical trial, an increase in compensation and other employee-related expenses associated with increased headcount, partially offset by one-time equity-based and patent-related charges of $2.1 million associated with Synlogic’s MIT-BU license agreement.

General and administrative expenses for the three months ended June 30, 2018 were $4.7 million compared to $3.0 million for the corresponding period in 2017. The increase was primarily due to an increase of $1.2 million in compensation costs associated with the separation of Synlogic’s former chief executive officer, as well as compensation and other employee-related expenses associated with increased headcount.

Revenues were $0.3 million for the three months ended June 30, 2018, compared to $2.1 million for the corresponding period in 2017. Revenue for both periods was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease (IBD). The decrease in revenue was primarily the result of a milestone achieved and recognized during the three months ended June 30, 2017.

Six-months Results
For the six months ended June 30, 2018, the consolidated net loss was $25.8 million, or $1.14 per share, compared to a consolidated net loss of $16.8 million, or $9.20 per share, for the corresponding period in 2017.

Total operating expenses were $27.6 million for the six months ended June 30, 2018, compared to $19.1 million for the corresponding period in 2017. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount, increased external costs associated with development of Synlogic’s Synthetic Biotic programs including process and formulation development, pre-clinical and clinical studies as well as increased general and administrative expenses as a consequence of becoming a public company.

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)

On August 7, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, reported its second quarter 2018 financial results for the period ended June 30, 2018 (Press release, Merrimack, AUG 7, 2018, View Source [SID1234528764]).

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"A cornerstone of Merrimack’s approach to drug development is our commitment to test targeted therapies in biomarker-enriched patient populations, resulting in smaller, shorter and more personalized studies that lower development costs and accelerate the timeframe to clinically meaningful data. This quarter, we have continued to demonstrate prudent adherence to this clinical strategy," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "Additionally, we are pleased to have strengthened our financial position with non-dilutive sources of capital, including an $18 million milestone announced today and the $15 million debt facility we closed in July, which we believe extend our cash runway into at least the first quarter of 2020 and position us to deliver on our corporate goals. Looking ahead, we anticipate significant progress across our pipeline, with two clinical readouts expected in the second half of 2018 from MM-121 in non-small cell lung cancer and MM-310 in solid tumors."

Key events from the second quarter and more recently include:

Receipt of $18 million milestone payment from Shire, resulting from the sale of ONIVYDE in two additional major European countries;

Closing in July of $25 million debt facility with Hercules Capital, $15 million of which was funded at closing, with eligibility for up to an additional aggregate of $10 million;

Announcement of top-line results from the CARRIE study, a randomized Phase 2 trial of MM-141 in front-line metastatic pancreatic cancer, in which MM-141 was added to standard-of-care chemotherapy treatments and evaluated in patients screened for high serum levels of the insulin-like growth factor-1 (IGF-1). As MM-141 did not demonstrate a clinical benefit in the study, Merrimack will cease all of its development activities for MM-141; and

Presentation of two posters at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 1-5, 2018 in Chicago, IL:

Clinical data from MM-121 (seribantumab) in a poster titled, "Evaluation of fixed-dose regimens of seribantumab in patients with solid tumors," containing an analysis of pharmacokinetic and safety data comparing different dosing regimens from previous Phase 1 and Phase 2 studies of MM-121 in solid tumors. Data presented support use of the dosing regimen currently being evaluated in Merrimack’s two ongoing randomized Phase 2 studies of MM-121, SHERLOC in non-small cell lung cancer (NSCLC) and SHERBOC in HR+/HER2- metastatic breast cancer; and

A Trials-in-Progress poster for MM-310, Merrimack’s antibody-directed nanotherapeutic (ADN) targeting the EphA2 receptor, titled, "A Phase 1 study evaluating the safety, pharmacology and preliminary activity of MM-310 in patients with solid tumors."

Upcoming Clinical Milestones

Merrimack anticipates the following upcoming clinical milestones:

Top-line results in 2018 from the SHERLOC study, a randomized Phase 2 clinical trial evaluating MM-121, a fully human monoclonal antibody targeting the HER3 receptor, added to standard of care in patients with heregulin positive non-small cell lung cancer; and

Safety data and maximum tolerated dose in 2018 from the Phase 1 clinical trial of MM-310, an antibody-directed nanotherapeutic targeting the EphA2 receptor, in patients with solid tumors.

Second Quarter 2018 Financial Results

The following summarizes Merrimack’s financial results for the quarter ended June 30, 2018:

Research and development expenses for the second quarter ended June 30, 2018 were $13.7 million, compared to $19.8 million for the comparable period of 2017. Research and development spending for the second quarter of 2018 was lower versus the comparable period in 2017 primarily due to Merrimack’s refocused clinical and preclinical pipeline;

General and administrative expenses for the second quarter ended June 30, 2018 were $3.5 million, compared to $14.8 million for the comparable period of 2017. General and administrative spending for the second quarter of 2018 was lower versus the comparable period in 2017 primarily due to a decrease in corporate expenses related to headcount levels following the asset sale to Ipsen;

Net loss for the second quarter ended June 30, 2018 was $17.8 million, or $1.33 per share, compared to a net loss of $28.9 million, or $2.18 per share, for the comparable period of 2017; and

As of June 30, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.

Financial Outlook

Merrimack believes that its cash, cash equivalents and marketable securities of $60.0 million as of June 30, 2018, in addition to $14.7 million in net borrowings from its July 2, 2018 loan and security agreement with Hercules Capital and the $18 million ONIVYDE milestone received from Shire, will be sufficient to fund its planned operations into at least the first quarter of 2020.

Merrimack remains eligible to receive additional milestone payments from Shire and Ipsen, resulting from the Company’s asset sale to Ipsen in 2017:

Merrimack is entitled to receive up to an additional $15 million in milestone payments from Shire, which are excluded from the Company’s cash runway guidance until achieved, consisting of:

$5.0 million related to the sale of ONIVYDE in the first major non-European, non-Asian country; and

$10.0 million for the first patient dosed in a pivotal clinical trial in an indication other than pancreatic cancer.

Merrimack is also entitled to receive up to an aggregate of $450 million in regulatory-based milestone payments from Ipsen, which Merrimack has said it expects to pass through to stockholders, net of any taxes owed and subject to there being sufficient surplus at that time, consisting of:

$225.0 million upon approval by the FDA of ONIVYDE for the first-line treatment of metastatic adenocarcinoma of the pancreas, subject to certain conditions;

$150.0 million upon approval by the FDA of ONIVYDE for the treatment of small cell lung cancer after failure of first-line chemotherapy; and

$75.0 million upon approval by the FDA of ONIVYDE for an additional indication unrelated to those described above.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Tuesday, August 7, 2018 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 6476538. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

Upcoming Investor Conferences

Merrimack is scheduled to present at the 2018 Baird Global Healthcare Conference on Thursday, September 6, 2018, at 8:30 am ET in New York. A live webcast of the presentation can be accessed under "Events and Presentations" in the Investors section of the Company’s website at www.merrimack.com. A replay of the webcast will be archived there for approximately 30 days following the presentation.