On July 17, 2019 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2019 (Press release, Abbott, JUL 17, 2019, View Source [SID1234537568]).

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Second-quarter worldwide sales of $8.0 billion increased 2.7 percent on a reported basis and 7.5 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.56 in the second quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.82, above the previous guidance range.
Abbott is raising its full-year 2019 outlook. Abbott projects organic sales growth of 7.0 to 8.0 percent1, diluted EPS from continuing operations on a GAAP basis of $2.06 to $2.12, and full-year adjusted diluted EPS from continuing operations of $3.21 to $3.27, reflecting double-digit growth.
FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, achieved worldwide sales of $433 million in the quarter, an increase of 63.9 percent on a reported basis and 72.9 percent on an organic basis versus the prior year. In the U.S., FreeStyle Libre is now reimbursed for approximately 75 percent of people with private pharmacy benefit insurance.
Worldwide sales of MitraClip were $169 million in the quarter, an increase of 26.7 percent on a reported basis and 30.6 percent on an organic basis versus the prior year, including U.S. growth of 56.1 percent. Earlier this week, Abbott announced U.S. FDA approval of its next-generation MitraClip device, which offers enhancements and more sizes to offer doctors further options.
In July, Abbott received U.S. FDA approval for its Alinity-S diagnostics system, the latest technology for screening and protecting the U.S. blood and plasma supply. Alinity-S is designed to provide faster and more efficient results within a smaller space versus commercially available competitive systems, while maintaining the highest levels of accuracy.
"Our sales growth accelerated and is sustainable," said Miles D. White, chairman and chief executive officer, Abbott. "We have great momentum and are raising our guidance above the strong outlook we previously set for the year."

* See note on organic growth below.

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes the prior year first and second-quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the second quarter:

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2019 worldwide sales of $8.0 billion increased 2.7 percent on a reported basis. On an organic basis, worldwide sales increased 7.5 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 0.9 percent on a reported basis in the second quarter. On an organic basis, sales increased 5.1 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 0.1 percent on a reported basis in the second quarter, including an unfavorable 2.8 percent effect of foreign exchange, and increased 2.9 percent on an organic basis. Sales performance in the quarter was led by broad-based growth across several brands, and included above-market growth in several countries in Latin America and Asia.

Worldwide Adult Nutrition sales increased 2.0 percent on a reported basis in the second quarter and increased 7.9 percent on an organic basis. International Adult Nutrition sales increased 3.4 percent on a reported basis and 10.4 percent on an organic basis in the second quarter. Sales performance in the quarter was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Worldwide Diagnostics sales increased 1.7 percent on a reported basis in the second quarter, including an unfavorable 4.5 percent effect of foreign exchange, and increased 6.2 percent on an organic basis.

Core Laboratory Diagnostics sales increased 3.6 percent on a reported basis and 9.4 percent on an organic basis in the second quarter. Sales performance in the quarter was led by above-market growth internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments. In July, Abbott received U.S. FDA approval for its Alinity-S (blood and plasma screening) diagnostics system and several testing assays, designed to provide faster and more efficient results within a smaller space, while maintaining the highest levels of accuracy.

Molecular Diagnostics sales decreased 12.4 percent on a reported basis in the second quarter, including an unfavorable 3.1 percent effect of foreign exchange, and decreased 9.3 percent on an organic basis. As expected, sales growth in the quarter was negatively impacted by non-governmental organization (NGO) purchasing patterns in Africa.

Point of Care Diagnostics sales increased 5.0 percent on a reported basis in the second quarter, including an unfavorable 0.7 percent effect of foreign exchange, and increased 5.7 percent on an organic basis. Sales growth was led by Abbott’s market-leading i-STAT handheld system in the U.S. and internationally.

Rapid Diagnostics sales decreased 0.1 percent on a reported basis in the second quarter, including an unfavorable 2.9 percent effect of foreign exchange, and increased 2.8 percent on an organic basis. Organic sales growth was led by infectious disease testing in developed markets and cardio-metabolic testing globally.

Established Pharmaceuticals sales decreased 1.8 percent on a reported basis in the second quarter, including an unfavorable 7.9 percent effect of foreign exchange, and increased 6.1 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 1.4 percent on a reported basis in the second quarter, including an unfavorable 9.3 percent effect of foreign exchange, and increased 7.9 percent on an organic basis, which was led by strong growth across several countries, including India and China.

Other sales decreased 3.1 percent on a reported basis in the second quarter, including an unfavorable 3.2 percent effect of foreign exchange, and increased 0.1 percent on an organic basis. As expected, Other sales growth was negatively impacted in the quarter by the recent discontinuation of a non-core, low-margin supply agreement.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Note: Insertable Cardiac Monitor (ICM) sales, which had previously been reported in Electrophysiology, are now included in Rhythm Management. Historical periods have been adjusted to reflect this change.

Worldwide Medical Devices sales increased 6.4 percent on a reported basis in the second quarter and increased 10.5 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, growth was led by strong performance in cardiac diagnostic and ablation catheters, which are used to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, growth was driven by market adoption of Abbott’s HeartMate 3 left ventricular assist device following U.S. FDA approval as a destination (long-term use) therapy in late-2018.

Growth in Structural Heart was led by MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation (backflow of blood through a leaky mitral heart valve). Earlier this year, Abbott received U.S. FDA approval for a new, expanded indication for MitraClip to treat clinically significant secondary mitral regurgitation as a result of underlying heart failure. This new indication significantly expands the number of people that can be treated with MitraClip. Earlier this week, Abbott announced U.S. FDA approval of its next-generation MitraClip device, MitraClip G4, which offers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.

In Diabetes Care, sales increased 28.2 percent on a reported basis and 35.3 percent on an organic basis in the second quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $433 million, an increase of 63.9 percent on a reported basis and 72.9 percent on an organic basis versus the prior year.

ABBOTT’S GUIDANCE FOR 2019
Abbott projects 2019 organic sales growth of 7.0 to 8.0 percent1, and diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $2.06 to $2.12. Abbott forecasts net specified items for the full year 2019 of $1.15 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.21 to $3.27 for the full year 2019.

Abbott is issuing third-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.53 to $0.55. Abbott forecasts specified items for the third quarter 2019 of $0.30 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.83 to $0.85 for the third quarter.

ABBOTT DECLARES 382ND CONSECUTIVE QUARTERLY DIVIDEND
On June 14, 2019, the board of directors of Abbott declared the company’s quarterly dividend of $0.32 per share. Abbott’s cash dividend is payable Aug. 15, 2019, to shareholders of record at the close of business on July 15, 2019.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On July 17, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported that Charles Wilson, Ph.D., President and Chief Executive Officer, will present a corporate overview at the Wedbush PacGrow Healthcare Conference on Wednesday, August 14, 2019, at 9:45 a.m. EDT in New York City (Press release, Unum Therapeutics, JUL 17, 2019, View Source [SID1234537566]).

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The presentation will be webcast live, and available for replay on the "Events" section of Unum’s investor relations webpage (investors.unumrx.com/events), where it will be archived for approximately 90 days.

On July 17, 2019 Orum Therapeutics reported an oversubscribed $30 million Series B financing. New investors, IMM Investment, Smilegate Investment, KTB Network, and Stassets Investment, join existing investors, InterVest and KB Investment/Solidus Investment in the financing (Press release, Orum Therapeutics, JUL 17, 2019, View Source [SID1234537556]). The proceeds of the financing will be used to expand Oromab, Orum’s proprietary cell-specific, cell-penetrating antibody platform technology that targets "undruggable" proteins and delivers a variety of therapeutic payloads. The company is applying the Oromab platform to discover and develop novel therapeutics for cancer and rare diseases, both internally and with partners. The financing will also further expand Orum’s R&D labs in Korea and Boston, where the company was recently accepted into a biotech incubator in Kendall Square, Cambridge.

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"A large number of important therapeutic targets are currently considered ‘undruggable,’ making drug discovery for these targets technically challenging," said Sung Joo Lee, Ph.D., Founder and CEO of Orum Therapeutics. "By intracellular delivery of antibodies, our platform redefines what undruggable means."

Using the Oromab platform, Orum builds antibodies that bind cell-specific receptors and are internalized through receptor-mediated endocytosis. With Orum’s proprietary design, these antibodies escape the early endosome into the cytosol. Once in the cytosol, the antibodies can be therapeutically active and directly target disease-causing proteins or deliver payloads. With the Oromab platform, Orum is exploring several therapeutic avenues: 1) inhibiting Ras and tumor-specific intracellular oncogenic drivers, 2) delivery of oligonucleotides or enzymes for cancer and rare diseases, and 3) targeted degradation of disease proteins.

"Orum’s cell-penetrating antibody platform is unique in that, it has the capacity to not only transform the landscape of druggable targets, but also overcome the limitation of cytosolic delivery of other therapeutic modalities," said Peter Park, Ph.D., Chief Scientific Officer of Orum Therapeutics.

On July 16, 2019 Cytori Therapeutics, Inc. (Nasdaq: CYTX) (the "company") reported a new direction and identity (Press release, Cytori Therapeutics, JUL 16, 2019, View Source [SID1234572285]).

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Since the beginning of 2019, the company has successfully evaluated and transformed its pipeline to place a stronger emphasis on product candidates that can maximize returns for shareholders and make a clinically meaningful impact for patients. Plus Therapeutics, Inc. plans to create and realize this value by developing drugs for niche and orphan markets, initially in oncology, that address significant unmet or substantially underserved medical needs and that represent global revenue opportunities estimated to be $250 million or more. We intend to focus our development activities in ways that can leverage the U.S. FDA’s accelerated regulatory pathways and enable the company to apply its in-house expertise in nanoparticle drug design, complex formulation, and drug manufacturing and scale-up.

"Our core development concept will be to combine known active pharmaceutical ingredients, or drugs, with new delivery approaches and/or formulations, resulting in innovative therapies with improved safety, efficacy, and/or convenience," said Marc H. Hedrick MD, President and CEO.

The company’s initial development focus will be on DocePLUS (formerly ATI-1123) — a complex, injectable, patented, albumin-stabilized pegylated liposomal docetaxel — for which a U.S. Phase 1 clinical trial has been completed and published. The company has previously announced that it has received feedback from the U.S. FDA that a 505(b)(2) new drug application appears to be an acceptable regulatory approach for DocePLUS. Plus Therapeutics intends to submit a Phase 2 clinical trial protocol in Small Cell Lung Cancer patients with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy to the U.S. FDA in the second half of 2019.

Coinciding with this new focus on DocePLUS, the company has determined that DoxoPLUS (formerly ATI-0918) –- a generic pegylated liposomal doxorubicin — no longer satisfies the aforementioned development and revenue criteria. As a result, we have elected to focus on divesting DoxoPLUS and are currently presenting this opportunity to external parties.

To complement and reinforce the new company direction, a new company brand will be established. We have created, designed, and launched a new company visual identity, mission, vision, values, website, and social media sites based on the brand promise of ‘Delivering More For Patients’.

"We took a holistic approach to branding the company under the new Plus Therapeutics name," said Russ Havranek, Vice President, Marketing and Portfolio Management. "We believe that Plus Therapeutics will clearly align, drive, and navigate the business forward, ultimately helping patients who are battling cancer and other life-threatening diseases."

The company has reserved a new stock symbol, PSTV, and plans to submit notice of the company name change to the Nasdaq Stock Exchange. We expect to trade under the new symbol within the next few weeks. Until then, the company intends to continue to trade on Nasdaq under its current stock symbol, CYTX.

On July 16, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, and Abbisko Therapeutics, a company with an extensive pipeline of targeted therapeutics with first-in-class or best-in-class potential, reported they have entered into an agreement to develop and commercialize X4’s product candidate, mavorixafor, in combination with checkpoint inhibitors or other agents in Greater China for oncology indications. Mavorixafor is a potentially first-in-class, once-daily, oral, small molecule antagonist of chemokine receptor CXCR4 (Press release, Abbisko Therapeutics, JUL 16, 2019, View Source;article_id=104 [SID1234556282]).

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This agreement provides Abbisko with the exclusive rights in China, Taiwan, Hong Kong and Macau to develop and commercialize maxorixafor in combination with checkpoint inhibitors or other agents in oncology indications – including pancreatic cancer, ovarian cancer and triple negative breast cancer, which will be explored initially. X4 retains full rest-of-world rights to develop and commercialize mavorixafor outside of Greater China for all indications, and the ability to utilize any data generated pursuant to the Abbisko collaboration for rest-of-world development.

"We are pleased to enter into this strategic partnership with the experienced team at Abbisko. This collaboration enables us to leverage Abbisko’s research and development expertise to explore mavorixafor’s potential benefit in advanced cancer patients and to potentially capture value from the growing oncology markets in Greater China, while enabling X4 to maintain its focus on the company’s ongoing rare disease programs," commented Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. "Abbisko’s top-notch investor syndicate, strong leadership with global oncology R&D experience, and broad healthcare network in Greater China provide a complementary opportunity to expand mavorixafor’s potential for patients into solid tumor oncology indications, which represent areas of significant unmet need."

"Mavorixafor has demonstrated proof of concept and a favorable safety profile in a Phase 2 trial in patients with WHIM syndrome, which is caused by compromised immune cell trafficking. We look forward to further realizing mavorixafor’s potential in broad oncology indications in combination with immune checkpoint inhibitors and other therapies, for the benefit of patients with significant unmet medical needs," said Dr. Yaochang Xu, Chief Executive Officer of Abbisko Therapeutics. "Targeting CXCR4 has strong mechanistic rationales in oncology and we believe mavorixafor will bring transformative value to Abbisko’s portfolio with clear synergies with our internal pipeline programs."

About Mavorixafor

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).