ARCA BIOPHARMA ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On August 1, 2019 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the quarter ended June 30, 2019 and provided a corporate update (Press release, Arca biopharma, AUG 1, 2019, View Source [SID1234538067]).

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"We continue to make important progress on our lead development program Gencaro building on our GENETIC-AF Phase 2B clinical trial results, which were published in the Journal of the American College of Cardiology: Heart Failure," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "The U.S. FDA recently agreed to amend the Special Protocol Assessment agreement for our Phase 3 trial to include heart failure patients with preserved ejection fraction (HFpEF) and a left ventricular ejection fraction (LVEF) up to 55%, the upper boundary of the LVEF range in GENETIC-AF for which Gencaro exhibited effectiveness for preventing atrial fibrillation/flutter. The revised PRECISION-AF target population, patients with recent atrial fibrillation and heart failure with mid-range and preserved ejection fractions, is an underserved population and we believe our Phase 2B data indicates that Gencaro may have a positive impact for these patients."

Pipeline Update

GencaroTM (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

In April 2019, GENETIC-AF Phase 2B clinical trial results were published in the Journal of the American College of Cardiology: Heart Failure in the paper "GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population".
In July 2019, the U.S. Food and Drug Administration (FDA) agreed to amend ARCA’s Special Protocol Assessment (SPA) agreement for the Phase 3 PRECISION-AF clinical trial to expand the target trial population to include heart failure patients with left ventricular injection fractions (LVEF) > 40% and < 55%. Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF in the first quarter of 2020.
AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for heart failure (HF) and peripheral arterial disease (PAD).

Chemistry, manufacturing and controls (CMC) activities continued in the second quarter.
Subject to securing additional financing, IND-enabling non-clinical studies are anticipated to begin in the fourth quarter of 2019, and an IND submission is anticipated in the second half of 2020.
Second Quarter 2019 Summary Financial Results

Cash and cash equivalents were $9.97 million as of June 30, 2019, compared to $6.6 million as of December 31, 2018. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations, at its current cost structure, through the first quarter of 2020.

Research and development (R&D) expenses for the three months ended June 30, 2019 were $0.4 million compared to $1.2 million for the corresponding period of 2018. The decrease in R&D expenses was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial in 2018.

General and administrative (G&A) expenses for the three months ended June 30, 2019 were $1.1 million, compared to $1.0 million in the second quarter of 2018. The Company expects G&A expenses in 2019 to be consistent with those in 2018 as it maintains administrative activities to support its ongoing operations.

Total operating expenses for the three months ended June 30, 2019 were $1.5 million compared to $2.2 million for the corresponding period of 2018. The decrease in total operating expenses was primarily attributable to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial in 2018.

Net loss was $1.4 million, or $1.14 per share, for the second quarter of 2019 compared to $2.1 million, or $2.74 per share, for the second quarter of 2018.

The Company will need to raise additional capital, and/or complete a partnership or other possible strategic transaction, to fund future operations and develop Gencaro or any other product candidates.

IDEXX Laboratories Announces Second Quarter Results

On August 1, 2019 IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing, reported revenues of $620 million for the second quarter of 2019, an increase of 7% compared to the prior year period on a reported basis, and 9% on an organic basis (Press release, IDEXX Laboratories, AUG 1, 2019, View Source [SID1234538056]).

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Second quarter results were driven by CAG Diagnostics recurring revenue growth of 9% reported and 11% organic, net of an estimated 0.5% growth headwind related to Brexit order timing and equivalent day effects. Global results reflected 10% reported and 13% organic growth in IDEXX VetLab consumables, continued strong double-digit gains in U.S. reference laboratory diagnostic and consulting services revenues, and 8% reported and 9% organic revenue growth in rapid assay products revenues. High IDEXX VetLab consumables revenue growth was supported by a 21% year-over-year increase in Catalyst chemistry analyzer installed base, benefiting from 761 placements at new and competitive accounts in international markets, a 39% year-over-year increase, and 486 Catalyst placements in North America, an 8% year-over-year increase. Overall organic revenue growth results in the second quarter were moderated by comparisons to very strong prior year period instrument placement levels, and flat organic growth in livestock, poultry and dairy ("LPD") revenue, including declines in swine diagnostic testing related to the African swine fever epidemic in China.

Earnings per diluted share ("EPS") was $1.43 for the second quarter, representing reported EPS growth of 16% and comparable constant currency EPS growth of 19%. These results reflected continued strong CAG Diagnostics recurring revenue gains, which supported a higher than projected 140 basis point improvement in operating margins on a reported basis and 120 basis points on a constant currency basis.

The Company is refining its full year 2019 revenue growth outlook to 7.5% – 9% on a reported basis and 9.5% – 10.5% on an organic basis. This reflects adjustments to our reported revenue growth outlook related to updated projections for foreign exchange rate impacts, and a 0.5% reduction to the high end of previous organic growth guidance, incorporating second quarter results. The Company is refining its full year reported revenue growth guidance for CAG Diagnostics recurring revenues to 9% – 10.5% and reinforcing its organic revenue growth guidance of 11% – 12%, consistent with strong year-to-date trends. The Company is raising its 2019 EPS guidance range by $0.05 per share at mid-point to $4.82 – $4.92, reflecting $0.04 per share in benefit from a lower projected effective tax rate from higher share-based compensation tax benefits and $0.02 per share in operational improvement from raised expectations for full year operating margin improvement of 100 – 125 basis points on a constant currency basis and lower interest expense projections. These benefits are partially offset by a $0.01 per share negative impact related to updated foreign exchange rate assumptions. Our updated EPS guidance is for 13% – 15% in reported EPS growth, or 17% – 20% on a comparable constant currency basis, aligned with our long-term performance goals.

"IDEXX business momentum remained strong in the second quarter driven by high organic growth in CAG Diagnostics recurring revenues. The solid performance we continue to deliver is the result of a deep and talented global team, an unrelenting commitment to innovation, a unique multi-modal strategy and our durable recurring revenue business model. We’re well positioned to build on this foundation through the expansion of key initiatives like IDEXX Preventive Care, which is building momentum as a driver of increased diagnostic testing, supporting faster growth for engaged IDEXX customers," said Jay Mazelsky, the Company’s Interim President and Chief Executive Officer.

Second Quarter Performance Highlights

Companion Animal Group

The Companion Animal Group generated 8% reported and 10% organic revenue growth for the quarter, supported by CAG Diagnostics recurring revenue growth of 9% reported and 11% organic.

IDEXX VetLab consumables generated 10% reported and 13% organic revenue growth, net of a combined 1% negative growth impact related to Brexit related stocking orders which benefited the first quarter and reversed in the second quarter, and equivalent day impacts from international holiday timing. IDEXX VetLab consumables growth was supported by ongoing expansion of our global premium instrument installed base, as well as continued strong customer retention, increases in testing utilization and moderate price gains.
Reference laboratory diagnostic and consulting services generated 8% reported and 10% organic revenue growth. These results were driven by continued strong double-digit organic growth in the U.S., reflecting volume gains with existing customers, moderate net price realization and benefits from net customer additions. Global organic revenue growth rates were moderated by consistent mid single-digit revenue gains in international markets.
Rapid assay products generated 8% reported and 9% organic revenue growth, driven by continued volume gains in SNAP 4Dx Plus Tests, supported by planned promotional programs, increasing customer retention rates and moderate net price gains.
Veterinary software, services and diagnostic imaging systems revenue growth increased 9% on a reported basis and 7% on an organic basis, driven by growth in subscription-based service revenues, including continued expansion of our practice management platforms.

Water

Water achieved revenue growth of 6% on a reported basis and 10% on an organic basis in the second quarter, supported by continued strong growth in international markets and mid single-digit gains in the U.S.

Livestock, Poultry and Dairy ("LPD")

LPD revenue declined 5% on a reported basis and was flat on an organic basis for the second quarter, supported by growth in herd health screening and solid increases in pregnancy and poultry testing. These gains were offset by significant declines in swine diagnostic testing related to African swine fever outbreaks in China, and moderate declines in European disease eradication programs.

Gross Profit and Operating Profit

Gross profits increased 8% year-over-year, and gross margin was 57.7%, an increase of 50 basis points compared to prior year period results on a reported basis and 30 basis points on a constant currency basis. Gross margin improvement was driven by mix benefits from strong growth in IDEXX VetLab consumable and rapid assay revenues and lower relative IDEXX VetLab instrument revenue growth, and continued moderate CAG Diagnostics recurring revenue net price gains. Gains in these areas were partially offset by increased investments in reference laboratory capacity and systems, and expanded field software support resources.

Operating margin was 26.5% in the quarter, 140 basis points higher than the prior year period results on a reported basis and 120 basis points on a constant currency basis, supported by gross margin gains and operating expense leverage on high revenue growth. Operating expenses increased 4% on a reported basis and 6% on a constant currency basis, driven by increases in our CAG segment’s sales and marketing costs and research and development spending, with overall expense increases moderated by low constant currency growth in general and administrative costs.

2019 Financial Outlook

The following guidance for 2019 reflects the assumptions that for the remainder of 2019, the value of foreign currencies will remain at the following rates in U.S. dollars:

the euro at $1.11;
the British pound at $1.23;
the Canadian dollar at $0.75; and
the Australian dollar at $0.68;
and relative to the U.S. dollar:

the Japanese yen at ¥110.00;
the Chinese renminbi at RMB 6.97; and
the Brazilian real at R$3.85.
Outlook for 2019

We are refining our 2019 revenue outlook to $2,380 million – $2,410 million, reflecting expectations for reported revenue growth of 7.5% – 9% and organic revenue growth of 9.5% – 10.5%. At mid-point, the updated revenue outlook is $10 million below our previous guidance, including $5 million of impact related to updated foreign exchange estimates and $5 million in operational refinements related to our second quarter results, resulting in a 0.5% reduction to the high end of our earlier organic revenue growth guidance. Our outlook reflects expectations for CAG Diagnostics recurring reported revenue growth of 9% – 10.5% and consistent expectations for organic revenue growth of 11% – 12%. At the foreign exchange rate assumptions in 2019 noted above, we estimate that the effect of the stronger U.S. dollar will reduce full year 2019 reported revenue growth by approximately 1.5% to 2%.

We are updating our 2019 EPS outlook to $4.82 – $4.92 per share, reflecting an increase of $0.05 per share at mid-point, reflecting $0.04 per share of improvement related to updated estimates for share-based compensation tax benefits and $0.02 per share of benefit from improved expectations for full year operating performance supported by higher projected operating margin gains of 100 – 125 basis points on a constant currency basis and lower projected interest expense. For the full year, we now expect a foreign exchange headwind of $0.04 per share, a $0.01 higher impact compared to previously projected impact, net of projected hedge gains of approximately $11.5 million in 2019. The updated outlook represents EPS growth of 13% – 15% on a reported basis, and 17% – 20% on a comparable constant currency growth basis.

The Company continues to project free cash flow at approximately 60% – 65% of net income in 2019, including an estimated $70 million of capital spending related to the completion of our Westbrook, Maine headquarters expansion and the relocation and expansion of our core laboratory in Germany. For 2019, the Company projects capital spending of approximately $160 million – $175 million.

We now expect an effective tax rate of approximately 19.5% – 20%, incorporating expectations for a benefit from share-based compensation accounting of $12 million – $14 million or approximately 250 basis points. We are now projecting a reduction in weighted average shares outstanding of approximately 1%, and interest expense, net of interest income, of approximately $34 million reflecting current and projected borrowings.

Conference Call and Webcast Information

IDEXX Laboratories, Inc. will be hosting a conference call today at 8:30 a.m. (Eastern) to discuss its second quarter 2019 results and management’s outlook. To participate in the conference call, dial 1-800-230-1093 or 1-612-288-0337 and reference confirmation code 470018. Replay of the conference call will be available through Thursday, August 8, 2019 by dialing 1-800-475-6701 or 1-320-365-3844 and referencing replay code 470018. Individuals can access a live webcast of the conference call through a link on the IDEXX website, www.idexx.com/investors. An archived edition of the webcast will be available after 1:00 p.m. (Eastern) on that day via the same link and will remain available for one year.

New NCCN Guidelines Are First to Address Small Intestine Cancers; Updates Highlight Developments in Genetic Testing and Hereditary Risk for Colon and Other Intestinal Cancers

On August 1, 2019 The National Comprehensive Cancer Network (NCCN) reported publication of a new set of recommendations focused on cancer in the small intestine (Press release, NCCN, AUG 1, 2019, View Source [SID1234538055]). The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Small Bowel Adenocarcinoma (SBA) are the first treatment guidelines in the United States (and second worldwide) to address this rare cancer type that is increasing in incidence. Small bowel cancers (of which adenocarcinomas are the most common) are responsible for about three percent of all digestive system cancers, with an estimated 10,590 new cases expected in 2019.1

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"Historically, small bowel adenocarcinoma has been managed in the same way as colorectal cancer, because SBA is rare and, therefore, difficult to study," said Katrina Pedersen, MD, MS, Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, an SBA expert and member of the NCCN Guidelines Panel for Colorectal Cancer. "The new NCCN Guidelines for Small Bowel Adenocarcinoma were created to reflect new research and biologic insights over the past several years that show optimal SBA management can differ from colorectal cancer treatments. For example, we’re incorporating a different class of drugs called taxanes into SBA treatment and deemphasizing the use of EGFR inhibitors that do not show a clear benefit. Our goal is to improve outcomes by standardizing the diagnosis, staging, and multimodal treatment possibilities for SBA patients."

"Our panels work very hard to make sure the NCCN Guidelines are up to date and inclusive for any therapeutic advances," said Al B. Benson, III, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chair, NCCN Guidelines Panel for Colon/Rectal/Anal Cancers. "We do extensive review and discussion of all existing evidence, and are constantly exploring ways to provide a more comprehensive approach for patients. In the case of intestinal cancers, which include colon, rectal, anal, and now small intestine, we’re expanding the guidelines to cover rare subsets. These efforts are also reflected in personalized treatment recommendations for patients with tumors that have certain genetic mutations or characteristics, such as microsatellite instability-high (MSI-H), BRAF mutation, or HER2 overexpression. Hereditary risk assessment and screening are also essential components in caring for patients with intestinal cancers, since many are potentially preventable."

Rates for many other gastrointestinal malignancies have been on the decline in recent years, in part as a result of increases in screening. At the same time, rates for small bowel cancers have increased 1.8 percent between 2006 and 2015.2 There is not currently a consensus on screening for SBA, since it’s located higher on the gastrointestinal tract, and therefore is not detected during a routine colonoscopy. However, it has been shown to be associated with Lynch syndrome (among other familial syndromes), Crohn’s disease, and colitis.

NCCN recently released updates to the NCCN Guidelines for Genetic/Familial Risk Assessment: Colorectal Cancer—reflecting the commitment to enhancing surveillance strategies that would increase early colorectal cancer detection rates, particularly as it relates to individuals with a personal or family history. The extensive update includes a clarified step-by-step process for the assessment of hereditary colorectal cancer syndromes, and a greater emphasis on the importance of genetic counseling.

"Many of these changes reflect the widespread adoption of multi-gene panel testing for hereditary cancer syndromes, which allows assessment for even rare causes of polyposis and other cancer syndromes," explained Heather Hampel, MS, LGC, The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, member of the NCCN Guidelines Panel for Genetic/Familial Risk Assessment: Colorectal Cancer. "We’ve added a section on the principles of cancer risk assessment and counseling, and also refined the initial approach to assessing hereditary CRC syndromes, included rare genetic causes for multiple adenomatous polyps, and updated the criteria for evaluation of Lynch syndrome."

The NCCN Guidelines for Colorectal Cancer Screening were also recently updated. The panel of experts behind those guidelines is closely following any emerging studies regarding new colorectal cancer diagnoses in younger people.

"The panel has reviewed the recent data for initiating screening of average-risk individuals before age 50," said Dawn Provenzale, MD, MS, Duke Cancer Institute, Chair, NCCN Guidelines Panel for Colorectal Cancer Screening. "Based on those data, the panel continues to endorse screening of average risk individuals at age 50. The panel will continue to review this strategy and monitor data as they emerge."

The NCCN Guidelines for SBA, Colorectal Cancer Screening, and Genetic/Familial High-Risk Assessment: Colorectal are all available free-of-charge for non-commercial use at NCCN.org, or via the Virtual Library of NCCN Guidelines App for smartphone and tablet.

SenesTech, Inc. to Report Second Quarter 2019 Financial Results on Tuesday, August 13, 2019

On August 1, 2019 SenesTech, Inc. (NASDAQ: SNES), a developer of proprietary technologies for managing animal pest populations through fertility control, reported that will report financial results for its second quarter of 2019, ended June 30, 2019, after the market close on Tuesday, August 13, 2019 (Press release, SenesTech, AUG 1, 2019, View Source [SID1234538054]). The Company has scheduled a conference call that same day, Tuesday, August 13, 2019, at 5:00 pm ET, to review the results.

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Second Quarter 2019 Conference Call Details

Date and Time: Tuesday, August 13, 2019 at 5:00 pm ET

Call-in Information: Interested parties can access the conference call by dialing (844) 308-3351 or (412) 317-5407.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

To Ask a Question: There will be three options to ask a question during the call:

Questions can be asked live during the call-in portion of the conference call.
The live webcast will feature an option to submit questions in writing during the event.
If you are unable to attend the event, you can submit a question in advance to [email protected].
Replay: A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation #10134038. A webcast replay will be available in the Investor Relations section of the Company’s website at View Source for 90 days.

About SenesTech
SenesTech is changing the paradigm of pest management by targeting the root cause of the problem: reproduction.

ContraPest is an innovative technology with an approach

DaVita Inc. 2nd Quarter 2019 Results

On August 1, 2019 DaVita Inc. (NYSE: DVA) reported results for the quarter ended June 30, 2019 (Press release, DaVita, AUG 1, 2019, View Source [SID1234538053]).

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Second quarter 2019 financial highlights:

Completed the sale of our DMG division to Optum.
Consolidated revenues of $2,843 million.
Operating income of $462 million.
Cash flows from continuing operations of $574 million.

DaVita Medical Group sale: As previously disclosed, on June 19, 2019, we completed the sale of our DaVita Medical Group (DMG) division to Collaborative Care Holdings, LLC (Optum), a subsidiary of UnitedHealth Group Inc., for an aggregate purchase price of $4.34 billion, prior to certain adjustments specified in the related purchase agreement, as amended. We recorded a preliminary pre-tax net loss of approximately $23 million related to this divestiture.

Upon the completion of the DMG sale we were required to make mandatory prepayments on debt outstanding under our senior secured credit facility, and we subsequently used the full $4.47 billion in preliminary net proceeds received at closing to prepay term debt outstanding. As a result of these prepayments we recognized a charge of $12 million to write off debt discount and deferred financing costs.

Volume: Total U.S. dialysis treatments for the second quarter of 2019 were 7,520,587, or an average of 96,418 treatments per day, representing a per day increase of 2.6% over the second quarter of 2018. Normalized non-acquired treatment growth in the second quarter of 2019 as compared to the second quarter of 2018 was 2.1%.

Effective income tax rate: Our effective income tax rate on income from continuing operations was 23.5% and 24.6% for the three and six months ended June 30, 2019, respectively. This effective income tax rate is impacted by the amount of third party owners’ income attributable to non-tax paying entities. The effective income tax rate on income from continuing operations attributable to DaVita Inc. was 28.0% and 29.6% for the three and six months ended June 30, 2019, respectively.

Our effective income tax rate on income from continuing operations attributable to DaVita Inc. for the three and six months ended June 30, 2019 was further impacted by the write-off of deferred financing costs and other debt costs and the six months ended June 30, 2019 was also impacted by the goodwill impairment charge recognized in the first quarter of 2019. Excluding these items from the three and six months ended June 30, 2019, our effective income tax rate on adjusted income from continuing operations attributable to DaVita Inc. would have been 27.9% and 28.9% for the three and six months ended June 30, 2019, respectively.

Center activity: As of June 30, 2019, we provided dialysis services to a total of approximately 231,700 patients at 2,971 outpatient dialysis centers, of which 2,723 centers were located in the United States and 248 centers were located in nine countries outside of the United States. During the second quarter of 2019, we opened a total of 33 new dialysis centers, acquired three dialysis centers and closed two dialysis centers in the United States. In addition, we acquired five dialysis centers outside of the United States during the second quarter of 2019.

Share repurchases: During the quarter ended June 30, 2019, we repurchased a total of 2,059,976 shares of our common stock for approximately $112 million at an average price of $54.46 per share. We have also repurchased 4,214,205 shares of our common stock for $238 million at an average price of $56.43 per share from July 1, 2019 through July 17, 2019. On July 17, 2019, our Board of Directors terminated all remaining prior share repurchase authorizations available to the Company and approved a new share repurchase authorization in the amount of $2.0 billion.

On July 22, 2019, we commenced a modified "Dutch auction" tender offer for up to $1.2 billion of our common stock at a price per share not less than $53.50 and not more than $61.50. The tender offer will expire at 12:00 midnight Eastern time at the end of the day on August 16, 2019, unless extended or terminated. The tender offer is contingent on successful execution of the bank financing described below on terms reasonably acceptable to the Company.

Debt Transactions: As previously announced, we plan to enter into a new bank financing consisting of a $1.0 billion secured revolving loan facility, a $1.75 billion secured term loan A facility with a delayed draw feature and a $2.5 billion secured term loan B facility. We expect to use the proceeds from the bank financing to pay off the remaining balances outstanding under our Term Loan B and revolving line of credit under our existing senior secured credit facility, to call the Company’s outstanding 5.75% Senior Notes due 2022 (Senior Notes), to fund the tender offer described above, and to add cash to the balance sheet for potential future share repurchases, acquisitions, and other general corporate purposes. This press release does not constitute a call notice. The Company expects the call notice for the Senior Notes to be issued following completion of the bank financing.

As of July 31, 2019, $502 million and $650 million remained outstanding on our Term Loan B and revolving line of credit, respectively, under our existing senior secured credit facility.

Outlook:

As previously announced on July 22, 2019, the Company updated its adjusted operating income (a non-GAAP financial measure) guidance for fiscal year 2019 to a range of $1.64 billion to $1.70 billion. The Company’s prior guidance at the time for adjusted operating income for fiscal year 2019 was $1.54 billion to $1.64 billion.