On November 6, 2018 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal first-quarter 2019, provided an update on recent business highlights, revised its fiscal year 2019 financial guidance and provided fiscal second-quarter 2019 financial guidance (Press release, Myriad Genetics, NOV 6, 2018, View Source [SID1234530868]).

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"Earnings during the quarter exceeded expectations based upon strong hereditary cancer and new product volume growth," said Mark C. Capone, president and CEO, Myriad Genetics. "Late in the quarter we identified two issues that impacted revenue for GeneSight and prenatal testing and as a result we have revised revenue guidance for fiscal 2019. We view these issues as transitory and given the progress on profitability, earnings guidance for the fiscal year remains unchanged. As we realize synergies from the Counsyl acquisition, continue to grow new product volumes, and secure additional new product coverage decisions, we expect revenue growth and profitability to further accelerate."

Business Highlights

Hereditary Cancer

Achieved seventh consecutive quarter of year-over-year hereditary cancer testing volume growth.

A landmark study published in the Journal of the American Medical Association demonstrated the importance of Myriad’s unique variant reclassification program. The study, which evaluated over 1.45 million patient test reports over a 10-year period, found that approximately 25 percent of all variants of unknown significance were reclassified. Nine percent of these amended reports led to an upgrade of a previously unclassified variant to a deleterious mutation.

A recent study published in Obstetrics and Gynecology, which evaluated almost 4,000 women presenting at 15 OBGYN practices, found that when patients were screened using the National Comprehensive Cancer Network guidelines, 24 percent of women who provided family history information met criteria for hereditary cancer testing.

Added the 29th gene, HOXB13, to the myRisk Hereditary Cancer panel. Men with a deleterious mutation in the HOXB13 gene have up to a 52 percent lifetime risk of developing prostate cancer and should receive incremental screening.

GeneSight

GeneSight test volume increased 28 percent year over year.

A record 15,500 physicians, including almost 2,500 new ordering doctors, ordered a GeneSight test in the fiscal first quarter.

Anticipate acceptance of the landmark GUIDED study in the fiscal second quarter of 2019.

Published the results of the IMPACT study in the Journal of Psychiatric Research. In the study, patients treated by primary care physicians had 27 percent greater symptom improvement, 35 percent increased response and 63 percent greater remission than those treated by psychiatrists.

Published the results of the Optum health economic study in Personalized Medicine. The study found that patients in the GeneSight cohort had cost savings of $5,505 in the first year. This result was highly statistically significant even after adjusting for pre-test differences between the two arms. When evaluating the subset of patients with major depressive disorder, patients who received GeneSight had total cost savings of $6,050 in the first year which also was highly statistically significant.

Prenatal testing volume increased 16 percent year over year in the fiscal first quarter.

Announced publication of a large clinical utility study for ForeSight in Genetics in Medicine. The study found that the ForeSight test led to significant changes in pregnancy management with 77 percent of at risk couples taking steps to avoid having an affected offspring such as prenatal diagnostic testing and in-vitro fertilization.

Vectra

Published results of a study demonstrating the minimally important difference in Vectra scores in Clinical Rheumatology. This data will form the basis of the future Vectra medical management tool on the test report.

Received favorable guidelines supporting Vectra from Bendcare, a national organization representing greater than 160 rheumatologists in the United States.

Prolaris

Fiscal first-quarter revenue increased 59 percent year over year to $6.2 million with double-digit volume growth.

Announced positive coverage decision from Blue Shield of California for Prolaris. This decision increases total covered commercial lives for Prolaris by 5 million and the number of total commercial lives covered to over 25 million lives in the United States.

EndoPredict

Fiscal first-quarter revenue increased 33 percent year-over-year to $2.4 million.

myPath Melanoma

Received a positive draft local coverage determination from Noridian Healthcare Solutions for myPath Melanoma.

Received a positive guideline recommendation from the American Academy of Dermatology for use of myPath Melanoma in equivocal lesions.

Companion Diagnostics

Received our second FDA approval for patients with HER2- metastatic breast cancer for BRACAnalysis CDx in conjunction with Pfizer’s PARP inhibitor talazoparib.

Announced new research agreement with Pfizer in neo-adjuvant triple negative breast cancer using BRACAnalysis CDx.

Filed supplementary PMA for BRACAnalysis CDx for use in conjunction with AstraZeneca’s PARP inhibitor Lynparza for maintenance in first-line ovarian cancer.

Fiscal Year 2019 and Fiscal Second-Quarter 2019 Financial Guidance

Below is a table summarizing Myriad’s revised fiscal year 2019 and fiscal second-quarter 2019 financial guidance:

Myriad’s fiscal year 2019 and fiscal second-quarter 2019 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today and discuss the fiscal fourth-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, November 6, 2018, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-672-8962. International callers may dial 1-303-223-4363. All callers will be asked to reference reservation number 21897521. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On November 6, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the Credit Suisse 27th Annual Healthcare Conference on Tuesday, Nov. 13, 2018 at 10:20 a.m. MT (12:20 p.m. ET/5:20 p.m. GMT) from Scottsdale, Arizona (Press release, Alkermes, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375640 [SID1234530867]). In addition, Alkermes’ corporate presentation will be webcast live at the Jefferies London Healthcare Conference on Wednesday, Nov. 14, 2018 at 4:00 p.m. GMT (11:00 a.m. ET) from London, U.K. These presentations may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

On November 6, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its third-quarter 2018 financial results (Press release, Valeant, NOV 6, 2018, View Source [SID1234530865]).

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"In addition to another consecutive quarter of overall organic growth2, the Company delivered organic growth2 across all reporting segments and generated robust cash flow from operations in the third quarter of 2018," said Joseph C. Papa, chairman and CEO, Bausch Health. "These results demonstrate that our progress toward transformation is on track as we continue to execute within our core businesses, launch new products, resolve legacy issues and reduce the total quantum of our debt."

"As we look to the end of the year, we are maintaining our full-year revenue guidance range and raising our full-year Adjusted EBITDA (non-GAAP) guidance range," continued Mr. Papa.

Company Highlights

Executing on Core Businesses and Advancing Pipeline

Reported revenue in the Bausch + Lomb/International segment decreased by 7% compared to the third quarter of 2017, primarily due to divestitures and discontinuations; revenue in this segment grew organically2 by 3% compared to the third quarter of 2017, primarily due to volume increases in all businesses of the segment
Segment reported eighth consecutive quarter of organic revenue growth2
LUMIFY has become the number one physician-recommended brand in the Redness Reliever category3 and one of the top 2 brands in the category4, achieving a weekly market share of 26%5
Launched AQUALOX (Silicone hydrogel, or SiHy, daily) in Japan in September 2018
Grew revenue in the Salix segment by 2% compared to the third quarter of 2017 despite generic competition following the loss of exclusivity for UCERIS
XIFAXAN revenue increased by 11% compared to the third quarter of 2017
Launched PLENVU, a one-liter PEG bowel cleansing preparation for colonoscopies, in the United States
U.S. launch of LUCEMYRA, the first and only non-opioid medication for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, with US WorldMeds
Entered into an exclusive agreement with Dova Pharmaceuticals, Inc. to co-promote DOPTELET in the United States, for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
Entered into an amendment to an existing license agreement with Alfasigma S.p.A. (Alfasigma) to initiate a late-stage clinical program to study an investigational formulation of rifaximin in patients with Postoperative Crohn’s disease
Expanded microbiome research and discovery through strategic collaboration with Cedars-Sinai Medical Center
Continued efforts to stabilize the Ortho Dermatologics segment
The U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for ALTRENO Lotion for the treatment of acne vulgaris, and ALTRENO has now launched
The FDA has provided tentative approval of the NDA for BRYHALI Lotion for the topical treatment of plaque psoriasis in adult patients; the Company plans to launch BRYHALI Lotion, as scheduled, later this month, following receipt of final FDA approval, which is pending due to the expiration of exclusivity for a related product
The FDA accepted the resubmission of the NDA for DUOBRII6 Lotion for the topical treatment of plaque psoriasis with a PDUFA action date of Feb. 15, 2019
Released first annual Corporate Social Responsibility report
Addressing Debt

$522 million of cash generated from operations was used to repay more than $360 million of debt in the third quarter of 2018
Repaid $114 million of senior secured term loans and $250 million of revolver borrowings
Eliminated all mandatory amortization for the remainder of 2018
Additionally, on Oct. 26, 2018, redeemed $125 million aggregate principal amount of outstanding 7.50% unsecured Senior Notes due 2021, using cash generated from operations
Resolving Legal Issues

Achieved dismissals or other positive outcomes in resolving and managing litigation and investigations in approximately 60 matters since Jan. 1, 2018
Resolved the XIFAXAN intellectual property litigation with Actavis Laboratories FL, Inc., preserving market exclusivity for XIFAXAN 550 mg tablets until 20287
Resolved the legacy Salix investigation by the U.S. Securities and Exchange Commission with no monetary penalty; settlement remains subject to approval by the U.S. District Court for the Southern District of New York
Resolved outstanding arbitration with Alfasigma
Third-Quarter 2018 Revenue Performance
Total reported revenues were $2.136 billion for the third quarter of 2018, as compared to $2.219 billion in the third quarter of 2017, a decrease of $83 million, or 4%. Excluding the impact of the 2017 divestitures and discontinuations of $112 million and the unfavorable impact of foreign exchange of $30 million, revenue grew organically2 by 3% compared to the third quarter of 2017, driven by organic growth2 across all four segments.

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.147 billion for the third quarter of 2018, as compared to $1.234 billion for the third quarter of 2017, a decrease of $87 million, or 7%. Excluding the impact of divestitures and discontinuations of $94 million, and the unfavorable impact of foreign exchange of $29 million, the Bausch + Lomb/International segment grew organically2 by approximately 3% compared to the third quarter of 2017.

Salix Segment
Salix segment revenues were $460 million for the third quarter of 2018, as compared to $452 million for the third quarter of 2017, an increase of $8 million, or 2%, despite generic competition following the loss of exclusivity for UCERIS. Growth in the segment was driven by higher sales of XIFAXAN, as well as higher sales of RELISTOR, which grew 88% in the third quarter of 2018 compared to the third quarter of 2017.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $177 million for the third quarter of 2018, which was in line with the third quarter of 2017. Excluding the unfavorable impact of foreign exchange of $1 million, the Ortho Dermatologics segment grew organically2 by 1% compared to the third quarter of 2017. Revenues in the Global Solta business grew by 12% on a reported basis and by 15% organically2 compared to the third quarter of 2017, driven by demand and the launch of the Thermage FLX System in additional markets around the world.

Diversified Products Segment
Diversified Products segment revenues were $352 million for the third quarter of 2018, as compared to $356 million for the third quarter of 2017, a decrease of $4 million, or 1%. The decline in revenue was partially offset by growth in the Generics business. Excluding the impact of divestitures and discontinuations of $16 million, the Diversified Products segment grew organically2 by 4% compared to the third quarter of 2017.

Operating Income
Operating income was $117 million for the third quarter of 2018, as compared to an operating income of $38 million for the third quarter of 2017, an increase of $79 million. The increase in operating results for the third quarter of 2018 primarily reflects favorable Cost of Goods Sold (COGS) and Selling, General and Administrative Expenses (SG&A), partially offset by an increase in Research & Development (R&D).

Net Loss
Net loss for the three months ended Sept. 30, 2018 was $350 million, as compared to net income of $1.301 billion for the same period in 2017, a decrease of $1.651 billion. The decrease is primarily due to a tax benefit of $1.397 billion generated in the third quarter of 2017 as a result of the completion of internal tax reorganization efforts that the Company had begun in the fourth quarter of 2016.

Adjusted net income (non-GAAP) for the third quarter of 2018 was $403 million, as compared to $367 million for the third quarter of 2017, an increase of $36 million, or 10%. The increase was primarily due to a reduction in interest expense of $39 million in the third quarter of 2018 and a lower tax rate due to changes in product and geography mix.

Operating Cash
The Company generated $522 million of cash from operations in the third quarter of 2018, as compared to $490 million in the third quarter of 2017, an increase of $32 million, or 7%. The increase in cash from operations was attributable to profitable operating results and improved working capital.

EPS
GAAP Earnings Per Share (EPS) Diluted for the third quarter of 2018 was ($1.00), as compared to $3.69 for the third quarter of 2017.

Adjusted EBITDA(non-GAAP)
Adjusted EBITDA (non-GAAP) was $916 million for the third quarter of 2018, as compared to $951 million for the third quarter of 2017, a decrease of $35 million, or 4%.

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 $3.30 – $3.45 billion from $3.20 – $3.35 billion
The Company is taking proactive steps to improve working capital through an ongoing efficiency initiative, Project CORE (Cost Optimization and Revenue Enhancement). As part of Project CORE, the Company plans to proactively reduce U.S. channel inventory in the fourth quarter of 2018, which we expect will result in a reduction in revenue and a decrease in profit. Despite this anticipated reduction in revenue, the Company is maintaining full-year revenue guidance, primarily due to actual outperformance and changes in the expected timing of products losing exclusivity, and is raising Adjusted EBITDA (non-GAAP) guidance, primarily due to actual outperformance and lower actual and expected SG&A expense.

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. 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 $973 million at Sept. 30, 2018
The Company’s availability under the Revolving Credit Facility was approximately $980 million at Sept. 30, 2018
Conference Call Details

Date:

Tuesday, Nov. 6, 2018

Time:

8:00 a.m. ET

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

4973686

Replay Dial-in:

+1 (877) 344-7529 (United States)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10125383 (replay available until Nov. 13, 2018)

On November 6, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported that it will report its third quarter 2018 financial results on Tuesday, November 13, 2018 (Press release, RedHill Biopharma, NOV 6, 2018, View Source [SID1234530864]).

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The Company will host a conference call on Tuesday, November 13, 2018 at 8:30 a.m. EST to review the financial results and business highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-866-575-6539; International: +1-929-477-0402; and Israel: +972-3-376-1315. The access code for the call is: 2166581.

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, View Source Please access the Company’s website at least 15 minutes ahead of the conference call to register.

On November 6, 2018 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Monday, November 12, 2018 following release of its third quarter 2018 financial results (Press release, Oncolytics Biotech, NOV 6, 2018, View Source [SID1234530862]).

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The live call may be accessed by dialing (888) 231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at 855-859-2056, using the replay code 6463668 and will be available for six months.

A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for six months