Blueprint Medicines to Present at Upcoming Investor Conferences

On February 19, 2020 Blueprint Medicines Corporation (NASDAQ:BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported its participation in fireside chats at the following upcoming investor conferences (Press release, Blueprint Medicines, FEB 19, 2020, View Source [SID1234554514]):

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9th Annual SVB Leerink Global Healthcare Conferencein New York, NY on Wednesday, February 26, 2020 at 9:00 a.m. ET.
40th Annual Cowen Health Care Conferencein Boston, MA on Tuesday, March 3, 2020 at 12:00 p.m. ET.
A live webcast of each presentation will be available by visiting the Investors & Media section of Blueprint Medicines’ website at View Source A replay of the webcasts will be archived on Blueprint Medicines’ website for 30 days following each presentation.

United Therapeutics Corporation to Report Fourth Quarter and Full Year 2019 Financial Results Before the Market Opens on Wednesday, February 26, 2020

On February 19, 2020 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its fourth quarter and full year 2019 financial results before the market opens on Wednesday, February 26, 2020 (Press release, United Therapeutics, FEB 19, 2020, View Source [SID1234554531]).

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United Therapeutics will host a teleconference on Wednesday, February 26, 2020, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing (866) 209-9943 in the United States, with international callers dialing +1 (825) 312-2282. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing (800) 585-8367 in the United States, with international callers dialing +1 (416) 621-4642, and using access code: 1598163.

This teleconference is also being webcast and can be accessed via United Therapeutics’ website at View Source

Controlling CAR T Cells with Light Selectively Destroys Skin Tumors in Mice

On February 19, 2020 University of California San Diego reported that have developed a control system that could make CAR T-cell therapy safer and more powerful when treating cancer (Press release, UCSD, FEB 19, 2020, View Source [SID1234554628]). By programming CAR T cells to switch on when exposed to blue light, the researchers controlled the cells to destroy skin tumors in mice without harming healthy tissue.

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In tests in mice, administering the engineered CAR T cells and stimulating the skin tumor sites with blue LED light reduced tumor size by eight to ninefold. The results were observed in nine out of ten mice tested. Engineered CAR T cells on their own did not inhibit tumor growth.

The work is published Feb. 19 in Science Advances.

Chimeric antigen receptor (CAR) T-cell therapy is a promising new approach to treat cancer. It involves collecting a patient’s T cells and genetically engineering them to express special receptors on their surface that can recognize an antigen on targeted cancer cells. The engineered T cells are then infused back into the patient to find and attack cells that have the targeted antigen on their surface.

While this approach has worked well for some types of blood cancer and lymphoma, it so far has not worked well against solid tumors. One reason is because many targeted cancer antigens are also expressed on healthy cells.

"It is very difficult to identify an ideal antigen for solid tumors with high specificity so that CAR T cells only target these diseased tumor sites without attacking normal organs and tissues," said Peter Yingxiao Wang, a professor of bioengineering at the UC San Diego Jacobs School of Engineering and the senior author of the study. "Thus, there is a great need to engineer CAR T cells that can be controlled with high precision in space and time."

To create such cells, Wang and his team installed an on-switch that would allow them to activate the CAR T cells at a specific site in the body. The switch uses two engineered proteins located inside the CAR T cell that bind when exposed to one-second pulses of blue light. Once bound together, the proteins trigger expression of the antigen-targeting receptor.

Since light cannot penetrate deeply in the body, Wang envisions that this approach could be used to treat solid tumors near the surface of the skin. For future studies, Wang is looking to collaborate with clinicians to test the approach on patients with melanoma.

Paper title: "Engineering Light-controllable CAR T Cells for Cancer Immunotherapy." Co-authors include Ziliang Huang*, Yiqian Wu*, Molly Allen, Yijia Pan, Phillip Kyriakakis, Shaoying Lu, Ya-Ju Chang, Xin Wang and Shu Chien, UC San Diego.

*These authors contributed equally to this work.

This work is supported by the National Institutes of Health and UC San Diego.

BAUSCH HEALTH COMPANIES INC. ANNOUNCES FOURTH-QUARTER AND FULL-YEAR 2019 RESULTS AND PROVIDES 2020 GUIDANCE

On February 19, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its fourth-quarter and full-year 2019 financial results (Press release, Bausch Health, FEB 19, 2020, View Source [SID1234554479]).

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"In 2019, we delivered on our ‘pivot to offense’ strategy. Our fourth-quarter and full-year 2019 results demonstrated the consistency and durability of Bausch Health, as we reported our eighth consecutive quarter of organic revenue growth2 and our first full year of reported revenue growth since 2015," said Joseph C. Papa, chairman and CEO, Bausch Health. "The Salix and Bausch + Lomb/International segments are leading our resurgence with continued strong performance."

"During the year, we invested in our future by increasing our commitment to R&D and by deploying approximately $250 million for bolt-on acquisitions to enhance our current product portfolio and add to our development pipeline," Mr. Papa continued.

Company Highlights

Executing on Core Businesses and Advancing Pipeline

The Bausch + Lomb/International segment comprised approximately 55% of the Company’s reported revenue in 2019
___________________________
1 Please see the tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the nearest comparable GAAP measure.
2 Organic growth/change, a non-GAAP metric, is defined as a change on a period-over-period basis in revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations.

Reported revenue in the Bausch + Lomb/International segment increased by 2% in 2019 compared to 2018; revenue in this segment grew organically1,2 by 5% compared to 2018, driven by organic growth1,2 across all five business units

Delivered third consecutive year of organic revenue growth2 in 2019

Launched multiple products in 2019, including:

Ocuvite Eye Performance vitamins

PreserVision AREDS 2 Formula minigel eye vitamins

LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38%

Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses

Zen Multifocal scleral lens for Presbyopia

enVista toric MX60ET intraocular lens

Acquired licensing rights for several investigational products, including:

XIPERE (triamcinolone acetonide suprachoroidal injectable suspension), with a proposed indication of treatment for macular edema associated with uveitis

NOV033 (perfluorohexyloctane), a first-in-class drug with a novel mechanism of action to treat Dry Eye Disease associated with Meibomian gland dysfunction

EM-100, an investigational eye drop that, if approved, will be the first over-the-counter preservative-free eye drop for the treatment of itchy eyes associated with allergies

The Salix segment comprised approximately 23% of the Company’s reported revenue in 2019

Reported revenue in the Salix segment increased by 16% in 2019 compared to 2018

Reported revenue of XIFAXAN (rifaximin) increased by 22% in 2019 compared to 2018

Acquired TRULANCE (plecanatide), a treatment for adults with chronic idiopathic constipation and irritable bowel syndrome with constipation

Acquired dolcanatide, an investigational compound that has demonstrated proof-of-concept in treating patients with multiple gastrointestinal conditions

Entered into a licensing agreement with the University of California, Los Angeles to develop and commercialize a novel investigational compound for the treatment of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis

Acquired licensing rights for MT-1303 (amiselimod), a late-stage investigational sphingosine 1-phosphate (S1P) modulator for the treatment of inflammatory bowel disease, and conducted study to evaluate its cardiovascular safety

The Ortho Dermatologics segment comprised approximately 7% of the Company’s revenue in 2019

Reported revenues in the Global Solta business unit grew by 44% in 2019 compared to 2018, driven by continued strong demand for Thermage FLX system following the launch in the Asia Pacific region

Launched DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, for the topical treatment of plaque psoriasis in adults

Launched a cash-pay prescription program, Dermatology.com, and expanded it to all Walgreens U.S. retail pharmacy locations

Received approval from the U.S. Food and Drug Administration for ARAZLO (tazarotene) Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older; launch is planned for the first half of 2020

Strategic Capital Allocation and Debt Management

Increased Research and Development (R&D) in 2019 by 14%, or $58 million, compared to 2018
____________________________
3 The acquisition of licensing rights for NOV03 was announced in late 2019, and the upfront payment was made in early 2020.

Utilized approximately $1.100 billion in cash generated from operations to repay debt by approximately $900 million and for ‘bolt-on’ acquisitions in 2019

Refinanced $4.240 billion of debt in 2019 to extend maturities and provide flexibility

Raised $1.260 billion of debt in 2019 to fund the settlement of the legacy Valeant U.S. ‘stock drop’ litigation and pay the related financing fees and expenses

Fourth-Quarter and Full-Year 2019 Revenue Performance
Total reported revenues were $2.224 billion for the fourth quarter of 2019, as compared to $2.121 billion in the fourth quarter of 2018, an increase of $103 million, or 5%.

Total reported revenues were $8.601 billion for the full year of 2019, as compared to $8.380 billion for the full year of 2018, an increase of $221 million, or 3%. Excluding the unfavorable impact of foreign exchange of $112 million, the impact of a 2019 acquisition of $55 million and the impact of divestitures and discontinuations of $54 million, revenue grew organically1,2 by approximately 4% compared to the full year of 2018, driven by organic growth1,2 in the Salix and Bausch + Lomb/International segments.

Bausch + Lomb/International segment revenues were $1.238 billion for the fourth quarter of 2019, as compared to $1.205 billion for the fourth quarter of 2018, an increase of $33 million, or 3%. Excluding
___________________________________
4 To assist investors in evaluating the Company’s performance, we have adjusted for changes in foreign currency exchange rates. Change at constant currency, a non-GAAP metric, is determined by comparing 2019 reported amounts adjusted to exclude currency impact, calculated using 2018 monthly average exchange rates, to the actual 2018 reported amounts.

the impact of divestitures and discontinuations of $6 million, the Bausch + Lomb/International segment grew organically1,2 by approximately 3% compared to the fourth quarter of 2018, primarily due to growth in the Global Consumer, Global Surgical and Global Vision Care business units.

Bausch + Lomb/International segment revenues were $4.739 billion for the full year of 2019, as compared to $4.664 billion for the full year of 2018, an increase of $75 million, or 2%. Excluding the unfavorable impact of foreign exchange of $110 million and the impact of divestitures and discontinuations of $41 million, the Bausch + Lomb/International segment grew organically1,2 by 5% compared to the full year of 2018, due to organic growth1,2 across all five business units.

Salix Segment
Salix segment revenues were $517 million for the fourth quarter of 2019, as compared to $426 million for the fourth quarter of 2018, an increase of $91 million, or 21%. The increase was primarily driven by XIFAXAN, which grew 29% as compared to the fourth quarter of 2018.

Salix segment revenues were $2.022 billion for the full year of 2019, as compared to $1.749 billion for the full year of 2018, an increase of $273 million, or 16%. Growth in the segment was primarily driven by higher sales of XIFAXAN, which grew 22% as compared to the full year of 2018, partially offset by the loss of exclusivity of products in the segment, primarily UCERIS (budesonide) and APRISO (mesalamine), which negatively impacted revenues by $96 million.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $158 million for the fourth quarter of 2019, as compared to $160 million for the fourth quarter of 2018, a decrease of $2 million, or 1%. The decline was due to lower volumes primarily driven by the loss of exclusivity of ELIDEL (pimecrolimus) Cream, 1%, ZOVIRAX (acyclovir) Cream, 5%, and SOLODYN (minocycline HCl), partially offset by higher revenues in the Global Solta business unit and revenues from new product launches in the Ortho Dermatologics business unit.

Ortho Dermatologics segment revenues were $565 million for the full year of 2019, as compared to $617 million for the full year of 2018, a decrease of $52 million, or 8%. The decline was due to lower volumes primarily driven by the loss of exclusivity of ELIDEL, ZOVIRAX, SOLODYN and ACANYA (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%, which negatively impacted revenues by $121 million, and was partially offset by higher revenues in the Global Solta business unit and revenues from new product launches in the Ortho Dermatologics business unit.

Diversified Products Segment
Diversified Products segment revenues were $311 million for the fourth quarter of 2019, as compared to $330 million for the fourth quarter of 2018, a decrease of $19 million, or 6%. Diversified Products segment revenues were $1.275 billion for the full year of 2019, as compared to $1.350 billion for the full year of 2018, a decrease of $75 million, or 6%. The decreases in revenue for both the fourth quarter and full year of 2019 were primarily attributed to the previously reported loss of exclusivity for a basket of products.

Operating Results
Operating loss was $1.076 billion for the fourth quarter of 2019, as compared to operating income of $25 million for the fourth quarter of 2018, a decrease of $1.101 billion. The decrease in operating results for the fourth quarter of 2019 was primarily driven by the accrual of legal reserves established

for the resolution of the legacy Valeant U.S. ‘stock drop’ litigation, other related actions and ongoing legacy litigation and investigations, partially offset by lower impairments and increased revenues in the fourth quarter of 2019 versus the fourth quarter of 2018.

Operating loss was $203 million for the full year of 2019, as compared to operating loss of $2.384 billion for the full year of 2018, a favorable change of $2.181 billion. The increase in operating results
primarily reflects goodwill impairment charges recognized in 2018 of $2.322 billion, decreases in the amortization and impairments of intangible assets and increased revenues and gross margins in 2019 versus 2018. The increase in operating results was partially offset by the accrual of legal reserves established for the resolution of the legacy Valeant U.S. ‘stock drop’ litigation, other related actions and ongoing legacy litigation and investigations.

Net Loss
Net loss for the fourth quarter of 2019 was $1.516 billion, as compared to net loss of $344 million for the same period in 2018, an unfavorable change of $1.172 billion. The change is primarily driven by the decrease of $1.101 billion in operating results as discussed above and higher income taxes, partially offset by lower interest expense and debt extinguishment charges.

Net loss for the full year of 2019 was $1.788 billion, as compared to net loss of $4.148 billion for the same period in 2018, a favorable change of $2.360 billion. The change is primarily driven by the increase of $2.181 billion in operating results as discussed above and lower interest expense and debt extinguishment charges.

Adjusted net income (non-GAAP)1 for the fourth quarter of 2019 was $404 million, as compared to $368 million for the fourth quarter of 2018, an increase of $36 million, or 10%.

Adjusted net income (non-GAAP)1 for the full year of 2019 was $1.559 billion, as compared to $1.410 billion for the full year of 2018, an increase of $149 million, or 11%.

Cash Generated from Operations
The Company generated $234 million of cash from operations in the fourth quarter of 2019, as compared to $319 million in the fourth quarter of 2018, a decrease of $85 million, or 27%. The decrease in cash from operations was primarily attributed to the timing of payments and receipts in the ordinary course of business, partially offset by improved operating results.

The Company generated $1.501 billion of cash from operations in 2019, which was in line with 2018.

EPS
GAAP Earnings Per Share (EPS) Diluted for the fourth quarter of 2019 was ($4.30), as compared to ($0.98) for the fourth quarter of 2018. GAAP EPS Diluted for the full year of 2019 was ($5.08), as compared to ($11.81) for the full year of 2018.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $898 million for the fourth quarter of 2019, as compared to $858 million for the fourth quarter of 2018, an increase of $40 million, or 5%.

Adjusted EBITDA (non-GAAP)1 was $3.571 billion for the full year of 2019, as compared to $3.474 billion for the full year of 2018, an increase of $97 million, or 3%. The increase was due to higher

revenues, most notably in the Salix segment, which has favorable gross margins, partially offset by higher operating expenditures to support new product launches and R&D projects.

2020 Financial Outlook
Bausch Health provided guidance for the full year of 2020, as follows:

Full-Year revenues in the range of $8.65 – $8.85 billion

Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.50 – $3.65 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 a financial outlook, 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, cash equivalents and restricted cash were $3.244 billion5 at Dec. 31, 2019

The Company’s availability under the Revolving Credit Facility was $1.055 billion at Dec. 31, 2019

Basic weighted average shares outstanding for the fourth quarter of 2019 were 352.6 million shares. Diluted weighted average shares outstanding for the fourth quarter of 2019 were 359.2 million shares6

Basic weighted average shares outstanding for the full year of 2019 were 352.1 million shares. Diluted weighted average shares outstanding for the full year of 2019 were 357.2 million shares6

Genmab Publishes 2019 Annual Report

On February 19, 2020 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2019 (Press release, Genmab, FEB 19, 2020, View Source [SID1234554499]). Below is a summary of business progress in 2019, financial performance for the year and the financial outlook for 2020. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com. An online summary of the report is available at View Source

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Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2019 today, February 19, 2020 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join the call dial +1 631 510 7495 (US participants) or +44 2071 928000 (international participants) and provide conference code 4887886.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

2019 ACHIEVEMENTS

Business Progress
Daratumumab

U.S. FDA decision on Phase III MAIA multiple myeloma (MM) submission – achieved
U.S. FDA decision on Phase III CASSIOPEIA MM submission – achieved
Phase III COLUMBA MM subcutaneous daratumumab safety and efficacy analysis – achieved

Ofatumumab
·Phase III ASCLEPIOS I & II relapsing multiple sclerosis SubQ ofatumumab study completion and reporting – achieved

Tisotumab vedotin
·Phase II innovaTV 204 tisotumab vedotin recurrent / metastatic cervical cancer study enrollment complete by mid-year – achieved

Innovative Pipeline

Phase II enapotamab vedotin expansion cohort efficacy analysis – achieved
Phase I/II HexaBody-DR5/DR5 initial clinical data – initial data now anticipated in 2020
Phase I/II epcoritamab (DuoBody-CD3xCD20) clinical data dose escalation cohorts – achieved
File INDs and/or CTAs for 3 new product candidates – achieved
U.S. IPO

Genmab successfully completed an initial public offering (IPO) of American Depositary Shares (ADSs) on the Nasdaq Global Select Market
Achievement made Genmab a dual-listed company listed on both the Nasdaq Copenhagen in Denmark and the Nasdaq Global Select Market in the U.S.
Financial Performance

Revenue was DKK 5,366 million in 2019 compared to DKK 3,025 million in 2018. The increase of DKK 2,341 million, or 77%, was mainly driven by higher DARZALEX royalties and milestones achieved under our daratumumab collaboration with Janssen.
Operating expenses increased by DKK 1,083 million, or 66%, from DKK 1,645 million in 2018 to DKK 2,728 million in 2019 driven by the advancement of tisotumab vedotin and enapotamab vedotin, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 2,638 million in 2019 compared to DKK 1,380 million in 2018. The improvement of DKK 1,258 million, or 91%, was driven by higher revenue, which was partly offset by increased operating expenses.
2019 year-end cash position of DKK 10,971 million, an increase of DKK 4,865 million, or 80%, from DKK 6,106 million as of December 31, 2018.
2020 OUTLOOK

Revenue
We expect our 2020 revenue to be in the range of DKK 4,750 – 5,150 million, compared to DKK 5,366 million in 2019. Our revenue in 2019 included DKK 1,684 million related to one-time sales milestones for DARZALEX net sales exceeding USD 2.5 billion and 3.0 billion in a calendar year.

Our projected revenue for 2020 primarily consists of DARZALEX royalties of DKK 4,075 – 4,475 million. Our 2020 guidance for DARZALEX royalties represents a 30% to 43% increase compared to 2019. Such royalties are based on estimated DARZALEX net sales of USD 3.9 – 4.2 billion. We project cost reimbursement income of approximately DKK 475 million which is related to our collaborations with Seattle Genetics and BioNTech. The remainder of our revenue is approximately DKK 200 million and consists of milestones and other royalties.

Operating Expenses
We anticipate our 2020 operating expenses to be in the range of DKK 3,850 – 3,950 million, compared to DKK 2,728 million in 2019. The increase is driven by the advancement of our clinical programs, particularly epcoritamab (DuoBody-CD3x-CD20) and DuoBody-PD-L1x4-1BB.

Operating Result
We expect our operating income to be in the range of DKK 850 – 1,250 million in 2020 compared to DKK 2,638 million in 2019.