On August 1, 2019 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2019 (Press release, Cerus, AUG 1, 2019, View Source [SID1234538069]).

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Recent developments and highlights include:

Total second quarter revenue of $22.5 million
Record quarterly product revenue of $18.2 million, an 18% increase compared to the prior year quarter
Government contract revenue of $4.3 million
Worldwide disposable kit demand increased 23% in the quarter compared to the prior year quarter
Raising 2019 full year product revenue guidance to a range of $72 million to $75 million from $71 million to $74 million given the strong demand for INTERCEPT
Cash, cash equivalents, and short-term investments of $96.2 million at June 30, 2019
Received European CE Mark approval for INTERCEPT plasma with DEHP-free plastic disposable kits
"We are pleased to report another strong quarter of commercial execution and record product revenues. Increasing customer adoption of INTERCEPT Blood Systems continues to be driven by the clinical, operational, and economic benefits conferred by our pathogen inactivation technology," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Robust demand for INTERCEPT kits was reported across multiple geographies with the greatest volume increase in the U.S. as blood centers and hospitals implement pathogen reduction in advance of the expected FDA final guidance document on bacterial risk control strategies for platelet collection and transfusion. In the face of increasing demand for our products from blood centers, we are continuing to invest in working capital, particularly in inventory."

"Pathogen-reduced cryoprecipitate continues to be an exciting pipeline opportunity and a product which could have a meaningful impact on improving patient outcomes. We now believe that we will be able to optimize the availability of plasma in order to realize manufacturing efficiencies for cryoprecipitate production with our blood center partners, potentially affording us with improved economics," continued Greenman.

Revenue

Product revenue during the second quarter of 2019 was $18.2 million, compared to $15.4 million during the same period in 2018. Revenue growth in the quarter benefited from the higher INTERCEPT kit demand in the U.S. and select international markets, partially offset by product mix in France and the strengthening of the U.S. dollar relative to the Euro compared to prior year exchange rates. Year-to-date product revenue totaled $35.7 million, an increase of 23% compared to the same period in 2018.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $4.3 million during the second quarter of 2019, compared to $4.0 million during the same period in 2018, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $8.7 million compared to $7.5 million in the first half of 2018. The total potential value of the current BARDA agreement is $201 million with $34 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the second quarter of 2019 were 55%, compared to 50% for the second quarter of 2018. The increase in gross margin was tied to economies of scale realized for our cost of goods sold and additional manufacturing efficiencies. Gross margins during the first half of 2019 were 54% compared to 48% reported in the first half of 2018.

Operating Expenses

Total operating expenses for the second quarter of 2019 were $31.2 million compared to $24.3 million for the same period the prior year. Year-to-date, operating expenses totaled $60.8 million compared to $47.4 million for the first half of 2018.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2019 totaled $16.7 million, compared to $14.4 million for the second quarter of 2018. The year-over-year increase in SG&A expenses was tied to higher investments in our manufacturing and supply chain capabilities. Year-to-date SG&A expenses totaled $32.9 million compared to $28.0 million for the first half of 2018.

Research and development (R&D) expenses for the second quarter of 2019 were $14.4 million, compared to $9.9 million for the second quarter of 2018. The increase in year-over-year R&D expenses was largely due to additional activities tied to the development of our INTERCEPT red blood cell system, including BARDA activities and initiatives aimed at ensuring supply and compatibility for our platelet and plasma products. Year-to-date R&D expenses totaled $27.9 million compared to $19.3 million for the first half of 2018.

Net Loss

Net loss for the second quarter of 2019 was $17.6 million, or $0.13 per diluted share, compared to a net loss of $13.3 million, or $0.10 per diluted share, for the second quarter of 2018. Year-to-date net loss was $36.4 million or $0.26 per diluted share compared to $27.2 million, or $0.21 per diluted share in the first half of 2018.

Cash, Cash Equivalents and Investments

At June 30, 2019, the Company had cash, cash equivalents and short-term investments of $96.2 million, compared to $117.6 million at December 31, 2018.

At June 30, 2019, the Company had approximately $39.3 million in outstanding term loan debt and $4.5 million of borrowings under its revolving loan credit agreement, compared to $29.9 million in outstanding term loan debt at December 31, 2018.

Revised 2019 Product Revenue Guidance

The Company now expects 2019 product revenue to be in the range of $72 million to $75 million compared to our previous guidance range of $71 million to $74 million. The new guidance range represents 18% to 23% growth compared to 2018 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2898719. The replay will be available approximately three hours after the call through August 15, 2019.

On August 1, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported a financial and pipeline update for the quarter ended June 30, 2019 (Press release, Acorda Therapeutics, AUG 1, 2019, View Source [SID1234538068]).

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"We made significant progress on the launch of Inbrija during the second quarter. Effective May 24, 2019, Inbrija became preferred on the Express Scripts National Preferred, Basic, and High Performance commercial national formularies, and we expect to reach agreements with other key payers in the near future," said Ron Cohen, M.D., Acorda’s President and CEO. "We have also been receiving encouraging feedback on Inbrija from both people with Parkinson’s and health care professionals. This is consistent with our market research and supports our expectation that Inbrija will become a standard of care."

Second Quarter 2019 Financial Results

For the quarter ended June 30, 2019, the Company reported INBRIJA net revenue of $3.0 million. INBRIJA became commercially available on February 28, 2019.

For the quarter ended June 30, 2019, the Company reported AMPYRA net revenue of $44.2 million compared to $150.3 million for the same quarter in 2018. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended June 30, 2019 were $19.0 million, including $0.8 million of share-based compensation compared to $25.9 million, including $1.5 million of share-based compensation for the same quarter in 2018.

Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2019 were $50.2 million, including $3.5 million of share-based compensation compared to $44.3 million, including $3.7 million of share-based compensation for the same quarter in 2018.

Provision for income taxes for the quarter ended June 30, 2019 was $0.2 million compared to a provision for income taxes of $8.4 million for the same quarter in 2018.

The Company reported a GAAP net loss of $27.5 million for the quarter ended June 30, 2019, or $0.58 per diluted share. GAAP net income in the same quarter of 2018 was $46.2 million, or $0.98 per diluted share.

Non-GAAP net loss for the quarter ended June 30, 2019 was $26.3 million, or $0.55 per diluted share. Non-GAAP net income in the same quarter of 2018 was $65.9 million, or $1.40 per diluted share. This quarterly non-GAAP net (loss) income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, and restructuring costs. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At June 30, 2019, the Company had cash, cash equivalents and short-term investments of $296.9 million. The Company has $345 million of convertible senior notes due in 2021 with a conversion price of $42.56.

2019 Financial Guidance

During INBRIJA’s launch year, the Company does not expect to provide INBRIJA revenue guidance.
The Company expects AMPYRA net revenue for the full year 2019 to be greater than $140 million.
R&D expenses for the full year 2019 are expected to be $70-$80 million and SG&A expenses for the full year 2019 are expected to be $200-$210 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Second Quarter 2019 Highlights

INBRIJA launch metrics through July 2019
– ~4,500 prescription request forms (PRFs)
– > 1,900 patients received a first dispense
– > 6,200 total cartons dispensed
– > 1,250 unique prescribers; ~50% repeat prescribers

Effective May 24, 2019, INBRIJA was made preferred on the Express Scripts National Preferred, Basic, and High Performance commercial national formularies.
In July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending INBRIJA’s approval by the European Commission (EC). The final EC decision is expected before the end of the year. Acorda is in discussions with potential partners to market INBRIJA in Europe.
Webcast and Conference Call

The Company will host a conference call today at 4:30 p.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 2287274. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on August 1, 2019 until 11:59 p.m. ET on August 31, 2019. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 2287274. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net (loss) income, adjusted to exclude the items below, and has provided 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net (loss) income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra monetization, and acquired Biotie debt, and (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, and (iv) expenses that pertain to non-routine restructuring events. The Company believes its non-GAAP net (loss) income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net (loss) income, we have provided 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

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.

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.

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.