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Savara to Report Third Quarter 2019 Financial Results and Provide Business Update

On October 31, 2019 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported that the Company will report third quarter 2019 financial results and provide a business update on Thursday, November 7, 2019 (Press release, Savara, OCT 31, 2019, View Source [SID1234550182]). Savara management will host a conference call/webcast with an accompanying slide deck at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT).

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Shareholders and other interested parties may access the call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and requesting the "Savara Inc." call. A live webcast of the call can be accessed on the Investors page of Savara’s website at View Source

Approximately one hour after the call, a telephone replay will be available and will remain available through November 14, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10135923. A webcast replay will be available on the Investors page of Savara’s website and will remain available for 30 days.

Entry into a Material Definitive Agreement.

On October 31, 2019,Tocagen Inc. (the "Company") reported that it entered into an amendment to its Loan and Security Agreement (the "Second Amendment") with Oxford Finance LLC, as Collateral Agent (the "Agent") and Silicon Valley Bank (the "Lenders"), dated May 18, 2018, as amended, pursuant to which the Lenders lent the Company $26.5 million in term loans (the "Term Loans") (Filing, 8-K, Tocagen, OCT 31, 2019, View Source [SID1234550181]).

Pursuant to the terms of the Second Amendment, the Lenders (i) agree to waive any prepayment fee otherwise applicable to a prepayment of the Term Loans in connection with any prepayment of the Term Loans on or after the date of the Second Amendment, (ii) consent to the sale of certain specified equipment, so long as the net cash proceeds from the sale of such assets are used to repay the Term Loans, and (iii) release their lien on the specified equipment upon the closing of any such sale.

The Company also has agreed to grant the Agent a security interest in the Company’s intellectual property as additional collateral to secure the Term Loans, pursuant to the Second Amendment for ratable benefit of the Lenders.

In connection with the Second Amendment, the Company made a prepayment of $23.3 million, which amount was used to prepay (A) a portion equal to $21.5 million of the outstanding principal of the Term Loans plus all accrued and unpaid interest thereon through the prepayment date, (B) pro rated portion of the final payment with respect to the portion of such Term Loans being prepaid, plus (C) all outstanding Lenders’ expenses as of the Second Amendment date.

After the date of the Second Amendment and prior to May 31, 2020, the Company may pay down portions of the Term Loans in amounts equal to not less than $500,000,which amount shall be used to prepay all or a portion of the outstanding principal of the Term Loans plus all accrued and unpaid interest thereon through the prepayment date, prorated portion of the final payment due with respect to the portion of such Term Loans being prepaid, plus all outstanding Lenders’ Expenses as of the prepayment date.

The foregoing is only a summary of the material terms of the Second Amendment, does not purport to be complete and is qualified in its entirety by reference to the full text of the Second Amendment, which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019.

ACG 2019 Plenary Presentation: A Novel EUS-guided Intratumoral Delivery of Submicron Particle Paclitaxel for the Treatment of Locally Advanced Pancreatic Cancer.

On October 31, 2019 Learmont Pharmaceuticals presented the corporate presentation (Press release, NanOlogy, OCT 31, 2019, View Source [SID1234550177]).

Hansa Biopharma Interim Report January-September 2019

On October 31, 2019 Hansa Biopharma reported Positive results from a pooled analysis of Phase 2 trials with imlifidase for desensitization in highly sensitized kidney transplant patients were presented for the first time at the European Society of Organ Transplantation’s (ESOT) Congress on September 17 (Press release, Hansa Biopharma, OCT 31, 2019, View Source [SID1234550164]). Imlifidase enabled kidney transplantation in 46 sensitized patients. The data presented was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

– Hansa Biopharma continued to advance imlifidase towards a potential marketing approval in the EU. A Marketing Authorization Application (MAA) for imlifidase for enabling kidney transplantation in highly sensitized patients is currently under review by the European Medicines Agency, EMA. An opinion from the Committee for Medicinal Products for Human Use is expected during the first half of 2020.

– In the United States, a follow-up meeting with the U.S. Food and Drug Administration (FDA) has been scheduled. At the meeting, the Company intends to continue the discussion from the December 2018 meeting regarding the path forward for a regulatory filing for imlifidase in kidney transplantation of highly sensitized patients in the U.S. The meeting will take place on November 20th, 2019. Minutes from the FDA meeting expected by end-of-December 2019.

– Our pipeline has advanced with the first patient treated within our Phase 2 study in acute Antibody Mediated Rejection (AMR). In the Anti-GBM study we enrolled 11 patients at the end of the third quarter.

– Hansa Biopharma continued building its’ medical and commercial organization to support a potential commercial launch of imlifidase in 2020: Investments in R&D and SG&A increased in the third quarter to SEK 47m (Q3’18: SEK 36m) and SEK 46m (SEK 24m) respectively.

– Cash flow from operating activities for the third quarter ended at SEK -80m (SEK -54m); the Company’s cash position was SEK 680m at the end of September 2019.

Søren Tulstrup, President and CEO, comments

"Hansa Biopharma’s evolution into a fully integrated, commercial biopharmaceutical company continues according to plan. During the first nine months of 2019 we made solid progress across the organization with the expansion of our global footprint, advancements in our pipeline and continued engagements with the healthcare community in transplantation, autoimmune diseases and beyond.

Our top priority is advancing our lead candidate, imlifidase, through market authorization to enable kidney transplants for highly sensitized patients. At the same time, we continue to develop our proprietary enzyme technology platform in rare autoimmune diseases, where there is a significant unmet medical need.

In September, Hansa Biopharma presented positive imlifidase data at the ESOT Congress in Copenhagen, Denmark. The data was based on a pooled analysis of highly sensitized kidney transplant patients from four single arm, 6-month, open label, Phase 2 trials of imlifidase treatment prior to deceased and living donor transplantation in sensitized patients. The analysis included 46 patients, of which 50% had a cPRA of 100%, 85% were crossmatch positive and 70% were re-transplanted. Following the treatment of imlifidase, the donor specific antibodies (DSA) levels rapidly decreased and all positive crossmatches were converted to negative, thus enabling transplantation of all patients. The data was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

In Europe, the regulatory review process for imlifidase is progressing as planned, following the acceptance of our Marketing Authorization Application end of February. We expect to receive an opinion from the committee for medical products of European Medicines Agency in the first half of 2020.

In the U.S., we recently confirmed a follow-up meeting with the FDA. The purpose of the meeting will be to continue the discussion from our December 2018 meeting regarding the path forward for a regulatory filing of imlifidase in kidney transplantation of highly sensitized patients in the U.S.

Talking about the U.S., we welcome the initiative by the current administration in the United States, who recently issued an executive order to improve the care of people with end stage renal disease (ESRD). Following the executive order, the U.S. Department of Health and Human Services (HHS) set out three specific goals for ESRD:

1) Reducing the number of Americans developing ESRD by 25 percent by 2030

2) Having 80 percent of new ESRD patients in 2025 either receiving a transplant or homecare dialysis

3) Doubling the number of kidneys available for transplant by 2030

In the U.S., approximately 37 million people have chronic kidney disease and more than 700,000 have ESRD. There are nearly 100,000 Americans waiting to receive a kidney transplant, and approximately 20% of the money spent on traditional Medicare in the U.S. are related to kidney disease. If approved, imlifidase may have the potential to help highly sensitized patients getting off dialysis by enabling transplantation.

We have also continued advancing our pipeline during the first 9 months of 2019, with the initiation of two Phase 2 studies in Guillain-Barré Syndrome (GBS) and acute Antibody Mediated Rejection (AMR) in kidney transplantation. In AMR, the first patient has now been treated with imlifidase. Our Anti-Glomerular Basement Membrane (Anti-GBM) program is also progressing as expected, with 11 patients enrolled so far and it’s our aim to complete enrollment in this study by year-end.

With the continued progress across the organization and significant progress for our lead candidate and pipeline activities, we are well-positioned to become a global biopharmaceutical company that brings lifesaving and life altering therapies to patients with rare diseases who need them and generate value to society at large. I look forward to updating you on our continued progress."

Søren Tulstrup

President and CEO of Hansa Biopharma

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on October 31, 2019.

IDEXX Laboratories Announces Third Quarter Results

On October 31, 2019 IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing, reported revenues of $605 million for the third quarter of 2019, an increase of 11% on a reported basis, and 12% on an organic basis, including over 1% in growth benefit related to equivalent business day effects (Press release, IDEXX Laboratories, OCT 31, 2019, View Source [SID1234550163]).

Third quarter results were driven by CAG Diagnostics recurring revenue growth of 13% reported and 14% organic, including a nearly 2% growth benefit related to equivalent business day effects. CAG Diagnostics recurring revenue results reflected strong 13% reported and organic revenue growth in the U.S. and international revenue growth of 12% reported and 16% organic. Global results reflected strong double-digit growth in IDEXX VetLab consumables, reference laboratory diagnostic and consulting services revenues, and high single-digit growth in rapid assay products revenues. IDEXX VetLab consumables revenue growth was supported by an 18% year-over-year increase in the Catalyst chemistry analyzer installed base, benefiting from 1,270 placements at new and competitive accounts globally, a 23% year-over-year increase. Overall organic revenue growth results in the third quarter were also supported by high single-digit organic growth in Water and livestock, poultry and dairy ("LPD") revenues.

Earnings per diluted share ("EPS") was $1.24 for the third quarter, representing reported EPS growth of 18% and comparable constant currency EPS growth of 21%. These results reflected benefits from strong CAG Diagnostics recurring revenue gains, which supported a higher than projected 160 basis point improvement in operating margins on a reported basis and 130 basis points on a constant currency basis.

The Company is updating its full year 2019 revenue growth outlook to 8% – 8.5% on a reported basis and 10% – 10.5% on an organic basis. This results in an increase of $5 million at midpoint, reflecting expectations for overall organic growth and CAG Diagnostics recurring organic revenue growth at the high end of previous estimates, incorporating strong third quarter results. This outlook is supported by expectations for CAG Diagnostics recurring reported revenue growth of 9.5% – 10% and organic revenue growth of 11.5% – 12%, consistent with strong year-to-date trends. The Company is lowering its 2019 EPS guidance range by $0.12 per share at mid-point to $4.72 – $4.78, as benefits from strong operating performance are offset by a projected $0.18 negative impact from CEO transition charges in the fourth quarter of 2019. Our updated 2019 EPS guidance is for 11% – 12% in reported EPS growth, or 15% – 16% on a comparable constant currency basis. Our EPS outlook reflects expectations for full year operating margin improvement of 55 – 70 basis points on a constant currency basis, including 55 basis points of unfavorable impact related to CEO transition charges in the fourth quarter of 2019.

The Company is providing preliminary 2020 guidance for reported and organic revenue growth of 9% – 10.5%, supported by sustained high growth CAG Diagnostics recurring revenues, and EPS of $5.30 – $5.46, supported by expectations of 100 – 150 basis points of constant currency operating margin expansion, including 50 basis points of benefit related to favorable comparisons to 2019 CEO transition charges. Reported 2020 EPS growth of 12% – 15% incorporates $0.11 of negative projected year-over-year impact from foreign exchange effects and a $0.12 year-over-year reduction in projected benefits from share-based compensation tax benefits. Adjusting for these impacts, the 2020 EPS guidance reflects projected year-over-year EPS growth of 17% – 20% on a comparable constant currency basis.

"IDEXX delivered outstanding operating results in the third quarter, supported by continued strong growth in CAG Diagnostics recurring revenues. Our high-return investments in our global commercial capability are driving the global adoption of our innovative products and services, including the rapid expansion of our Catalyst installed base and increased utilization of IDEXX’s proprietary Fecal Dx Antigen Panel and IDEXX SDMA test," said Jay Mazelsky, the Company’s President and Chief Executive Officer. Mazelsky continued," It is clear that our customers are benefiting from increased interaction and support from IDEXX engagement as we work together to advance the standard of companion animal healthcare. We are building on this momentum with an eight percent expansion of our U.S. field commercial capability in the fourth quarter of this year, which will position us well to continue delivering strong financial results aligned with our long-term goals."

Third Quarter Performance Highlights

Companion Animal Group

The Companion Animal Group generated 12% reported and 13% organic revenue growth for the quarter, supported by CAG Diagnostics recurring revenue growth of 13% reported and 14% organic, which included nearly 2% of growth benefit related to equivalent business day effects.

IDEXX VetLab consumables generated 16% reported and 18% organic revenue growth, including an estimated 3% of growth benefit related to equivalent business day effects. IDEXX VetLab consumables growth was supported by ongoing expansion of our global premium instrument installed base, continued strong customer retention, increases in testing utilization and moderate net price gains.
Reference laboratory diagnostic and consulting services generated 11% reported and 12% 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 supported by improved high single-digit revenue gains in international markets.
Rapid assay products generated 9% reported and 10% organic revenue growth, including an estimated 3% of growth benefit related to equivalent business day effects. Rapid assay revenue growth was supported by volume gains across our SNAP portfolio of products, including 4Dx Plus, high customer retention rates and moderate net price gains.
Veterinary software, services and diagnostic imaging systems revenue grew 6% on a reported and organic basis, driven by growth in subscription-based service revenues, including continued expansion of our practice management platforms. Overall segment growth was constrained by comparisons to very strong prior year digital imaging system placement levels.

Water

Water achieved revenue growth of 5% on a reported basis and 7% on an organic basis in the third quarter, supported by solid volume growth across all regions.

Livestock, Poultry and Dairy ("LPD")

LPD generated revenue growth of 7% on a reported basis and 10% on an organic basis for the third quarter. These results reflected revenue gains across the product portfolio including increases in diagnostic testing in Asia from new testing programs and from testing associated with alternative food sources, such as poultry. Third quarter results also benefited from favorable comparisons to soft prior year revenue levels in the Asia region. These gains were partially offset by moderate declines in herd health screening, compared to strong prior year levels, and continued impacts on swine testing from the prolonged outbreak of African swine fever in China.

Gross Profit and Operating Profit

Gross profits increased 13% year-over-year, and gross margin was 57%, an increase of 100 basis points compared to prior year period results on a reported basis and 60 basis points on a constant currency basis. Gross margin improvement was supported by mix benefits from strong growth in IDEXX VetLab consumables revenue, reference laboratory productivity gains and continued moderate CAG Diagnostics recurring revenue net price gains.

Operating margin was 23.1% in the quarter, 160 basis points higher than the prior year period results on a reported basis and 130 basis points on a constant currency basis, supported by gross margin gains and operating expense leverage on high revenue growth. Operating expenses increased 9% on a reported basis and 10% on a constant currency basis, driven by increases in our CAG segment’s sales and marketing costs and research and development spending.

2019 and 2020 Financial Outlook

The following guidance for 2019 and 2020 reflects the assumptions that for the remainder of 2019 and the full year 2020, the value of foreign currencies will remain at the following rates in U.S. dollars:

the euro at $1.09;
the British pound at $1.26;
the Canadian dollar at $0.75; and
the Australian dollar at $0.67;
and relative to the U.S. dollar:

the Japanese yen at ¥110.00;
the Chinese renminbi at RMB 7.22; and
the Brazilian real at R$4.21.
Outlook for 2019

We are updating our 2019 revenue outlook to $2,395 million – $2,405 million, reflecting expectations for reported revenue growth of 8% – 8.5% and organic revenue growth of 10% – 10.5%. At mid-point, the updated revenue outlook is $5 million above our previous guidance reflecting projected organic revenue growth at the higher end of our previous guidance range. Our outlook now reflects expectations for CAG Diagnostics recurring reported revenue growth of 9.5% – 10% and organic revenue growth of 11.5% – 12%. Modest benefits from a recently completed acquisition are offset by refinements to our foreign exchange rate assumptions. 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 2%.

We are updating our 2019 EPS outlook to $4.72 – $4.78 per share, reflecting a decrease of $0.12 per share at mid-point, incorporating a projected $0.18 negative impact from CEO transition charges in the fourth quarter of 2019 and a negative $0.02 per share impact related to updated foreign exchange assumptions. These impacts are partially offset by $0.06 in operational improvement related to strong third quarter performance and lower projections for net interest costs, as well as $0.02 per share of improvement related to updated estimates for share-based compensation tax benefits. For the full year, we now expect a foreign exchange headwind of $0.06 per share, net of projected hedge gains of approximately $11.5 million in 2019. The updated outlook represents EPS growth of 11% – 12% on a reported basis, and 15% – 16% on a comparable constant currency growth basis.

The Company continues to project free cash flow at approximately 60% – 65% of net income in 2019 and capital spending of approximately $160 million – $175 million, 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.

The Company provides the following updated guidance for 2019:

We now expect an effective tax rate of approximately 20%, including approximately 1% of impact related to CEO transition charges. The effective tax rate outlook incorporates expectations for share-based compensation tax benefits of $15 million or approximately 300 basis points, resulting in EPS benefits of $0.17 per share. We continue to project a reduction in weighted average shares outstanding of approximately 1%, and now expect interest expense, net of interest income, of approximately $31.5 million reflecting current and projected borrowings.

Preliminary Outlook for 2020

The Company provides the following preliminary guidance for 2020:

Amounts in millions except per share data and percentage

The Company’s 2020 outlook is for continued strong overall organic revenue growth, supported by sustained high growth in CAG Diagnostics recurring revenues.

At the foreign exchange rates assumed in this earnings release, we estimate that foreign exchange impacts will decrease 2020 reported revenue growth by approximately 0.5%, and EPS by approximately $0.11 per share, including impacts from comparisons to approximately $11.5 million of projected foreign exchange hedge gains in 2019.

Our 2020 EPS outlook includes approximately $0.04 – $0.06 per share of projected benefit from share-based compensation tax benefits, $0.12 per share below higher than expected 2019 levels at midpoint. Our preliminary outlook for our effective tax rate is 21% – 22% and for a reduction in weighted average shares outstanding from continued stock repurchases of approximately 1%. We are projecting interest expense, net of interest income, of approximately $36 million, reflecting current and projected borrowings and the assumed continuation of current floating interest rate costs.

Conference Call and Webcast Information

IDEXX Laboratories, Inc. will be hosting a conference call today at 8:30 a.m. (Eastern) to discuss its third quarter 2019 results and management’s outlook. To participate in the conference call, dial 1-800-230-1096 or 1-612-332-0335 and reference confirmation code 472946. Replay of the conference call will be available through Thursday, November 7, 2019 by dialing 1-800-475-6701 or 1-320-365-3844 and referencing replay code 472946. 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.