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Proteostasis Therapeutics Reports Third Quarter 2019 Financial Results and Provides Corporate Update

On November 7, 2019 Proteostasis Therapeutics, Inc. (NASDAQ:PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Proteostasis Therapeutics, NOV 7, 2019, View Source [SID1234550844]).

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"With equally strong demand from both US and ex-US clinical centers, we were able to complete enrollment in a little over four months for our 28-day global Phase 2 study of our doublet and triplet cystic fibrosis transmembrane conductance regulator (CFTR) combinations, and we now expect to report top line results later this quarter," said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics. "CFTR modulator therapy is on the threshold of transforming CF from a life limiting disease into a chronic condition, increasing life span and quality of life. Yet standard of care CFTR modulator treatment still leaves behind many people with CF, as tolerability, efficacy, access and eligibility remain disparate across patient populations. PTI is committed to delivering additional CFTR modulator treatment options to address these significant unmet needs."

Recent Highlights and Upcoming Milestones

Earlier this week, PTI announced the completion of enrollment in the Company’s 28-day, Phase 2 study evaluating its proprietary doublet (PTI-808 and PTI-801) and triplet (PTI-808, PTI-801 and PTI-428) CFTR modulator combinations, at doses selected based on the totality of dose range finding data from approximately 250 CF subjects studied thus far. The study design targeted up to 30 F508del homozygous and up to 30 F508del heterozygous subjects. Study endpoints include safety, changes in sweat chloride concentration and changes in percent predicted FEV1 (ppFEV1). Due to rapid enrollment from centers in the United States, Canada, Western Europe, and New Zealand, data from the study are now expected in the fourth quarter of 2019 instead of the first quarter of 2020.

Data from the Company’s CF clinical development programs were recently highlighted at the North American Cystic Fibrosis Conference in presentations delivered by Patrick Flume, M.D., Professor of Medicine and Pediatrics, Medical University of South Carolina and Jennifer L. Taylor-Cousar, M.D., M.S.C.S., Associate Professor of Medicine and Pediatrics, and Co-Director and CF Therapeutics Development Network Director of the Adult CF Program at National Jewish Health.

Last month, PTI hosted a cystic fibrosis patient summit on the disparity in access to CFTR modulator treatments. The event featured members of the CF community, including thought leaders, people with CF and CF advocates, and panel discussions focused on current unmet needs in CF.

In July, PTI announced the appointment of Geoffrey S. Gilmartin, M.D., M.M.Sc., as the Company’s Chief Medical Officer (CMO), and Andrey E. Belous, M.D., Ph.D., as a Senior Medical Director. Dr. Gilmartin served previously as the medical lead for the Kalydeco label expansion program at Vertex Pharmaceuticals Inc. Dr. Belous joined the Company from Galapagos NV, where he most recently served as a Medical Director for the Company’s Phase 3 program in Idiopathic Pulmonary Fibrosis (IPF).

Third Quarter 2019 Financial Results

Proteostasis reported a net loss of approximately $12.8 million for the three months ended September 30, 2019, as compared to a net loss of $18.4 million for the same period in the prior year.

There was no revenue for the three months ended September 30, 2019, as compared to $1.1 million for the same period in the prior year. The decrease of $1.1 million is due to the termination of the Company’s collaboration agreement with Astellas.

Research and development expenses for the three months ended September 30, 2019 were $10.1 million, as compared to $15.6 million for the same period in the prior year. The decrease was primarily due to a decrease in clinical-related research activities.

General and administrative expenses for the third quarter of 2019 were $3.2 million, as compared to $4.2 million for the same period in the prior year. The decrease in general and administrative expenses in these periods was due primarily to lower professional fees and facility expenses.

Cash, cash equivalents and short-term investments totaled $77.8 million as of September 30, 2019, compared to $88.0 million as of June 30, 2019. We believe that our existing cash, cash equivalents and short-term investments are sufficient to fund our operations into 2021, allowing us to complete our Phase 2 study and fund activities supporting our pathway to product registrations.

Penumbra, Inc. Reports Third Quarter 2019 Financial Results

On November 7, 2019 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, reported financial results for the third quarter ended September 30, 2019 (Press release, Penumbra, NOV 7, 2019, View Source [SID1234550843]).

Revenue of $139.5 million in the third quarter of 2019, an increase of 24.8%, or 25.5% in constant currency1, over the third quarter of 2018.
Third Quarter 2019 Financial Results
Total revenue grew to $139.5 million for the third quarter of 2019 compared to $111.8 million for the third quarter of 2018, an increase of 24.8%, or 25.5% on a constant currency basis. The United States represented 65% of total revenue and international represented 35% of total revenue for the third quarter of 2019. Revenue from sales of neuro products grew to $83.2 million for the third quarter of 2019, an increase of 11.5%, or 12.4% on a constant currency basis. Revenue from sales of vascular products grew to $56.3 million for the third quarter of 2019, an increase of 51.6%, or 52.0% on a constant currency basis.

Gross profit was $96.0 million, or 68.8% of total revenue, for the third quarter of 2019, compared to $75.0 million, or 67.1% of total revenue, for the third quarter of 2018.

Total operating expenses for the third quarter of 2019 were $83.0 million, or 59.5% of total revenue. This compares to total operating expenses of $95.9 million, or 85.7% of total revenue, for the third quarter of 2018, which included a $30.8 million acquired in-process research and development ("IPR&D") charge in connection with the acquisition of a controlling interest in MVI Health Inc. Excluding the IPR&D charge, total adjusted operating expenses2 (a non-GAAP measure) were $65.0 million, or 58.2% of total revenue, for the third quarter of 2018. R&D expenses were $13.7 million for the third quarter of 2019, compared to $9.1 million for the third quarter of 2018. SG&A expenses were $69.3 million for the third quarter of 2019, compared to $55.9 million for the third quarter of 2018.

Operating income for the third quarter of 2019 was $13.0 million. This compares to an operating loss of $20.8 million for the third quarter of 2018, including the IPR&D charge. Excluding the IPR&D charge, adjusted operating income2 (a non-GAAP measure) was $10.0 million for the third quarter of 2018.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss the third quarter 2019 financial results after market close on Thursday, November 7, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone by dialing (833) 227-5837 for domestic callers or (647) 689-4064 for international callers (conference id: 4746448), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

Mettler-Toledo International Inc. Reports Third Quarter 2019 Results

On November 7, 2019 Mettler-Toledo International Inc. (NYSE: MTD) reported third quarter results for 2019 (Press release, Mettler-Toledo, NOV 7, 2019, View Source [SID1234550842]). Provided below are the highlights:

Reported sales increased 3% compared with the prior year. In local currency, sales increased 4% in the quarter as currency reduced sales growth by 1%.
Net earnings per diluted share as reported (EPS) were $5.20, compared with $4.93 in the prior-year period. Adjusted EPS was $5.77, an increase of 13% over the prior-year amount of $5.12. Adjusted EPS is a non-GAAP measure, and we have included a reconciliation to EPS on the last page of the attached schedules.
Quarterly Results

Olivier Filliol, President and Chief Executive Officer, stated, "Local currency sales growth in the quarter excluding Food Retail, was 6%, with excellent growth in the Americas and solid growth in Europe and Asia/Rest of World. Despite continued challenges from the impact of adverse currency and tariff costs, we achieved strong margin improvement and earnings growth in the quarter."

GAAP Results
EPS in the quarter was $5.20, compared with the prior-year amount of $4.93.

Compared with the prior year, total reported sales increased 3% to $753.9 million. By region, reported sales increased 6% in the Americas and 2% in Asia/Rest of World. Reported sales in Europe declined by 2%. Earnings before taxes amounted to $169.4 million, compared with $160.4 million in the prior year.

Non-GAAP Results
Adjusted EPS was $5.77, an increase of 13% over the prior-year amount of $5.12.

Compared with the prior year, total sales in local currency increased 4% as currency reduced reported sales growth by 1%. By region, local currency sales increased 7% in the Americas, 2% in Europe and 4% in Asia/Rest of World. Adjusted Operating Profit amounted to $196.2 million, an 8% increase from the prior-year amount of $182.0 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Year-to-Date Results

GAAP Results
EPS was $14.67, compared with the prior-year amount of $12.81.

Compared with the prior year, total reported sales increased 2% to $2.165 billion. By region, reported sales increased 5% in the Americas and 3% in Asia/Rest of World. Reported sales in Europe declined 2%. Earnings before taxes amounted to $450.3 million, compared with $421.4 million in the prior year.

Non-GAAP Results
Adjusted EPS was $15.02, an increase of 11% over the prior-year amount of $13.50.

Compared with the prior year, total sales in local currency increased 5% as currency reduced reported sales growth by 1%. By region, local currency sales increased 5% in the Americas, 3% in Europe and 7% in Asia/Rest of World. Adjusted Operating Profit amounted to $521.8 million, a 6% increase from the prior-year amount of $490.8 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Outlook

Based on today’s assessment of market conditions, management anticipates that local currency sales growth in the fourth quarter 2019 will be approximately 3%, and Adjusted EPS is forecasted to be in the range of $7.66 to $7.71, an increase of 12% to 13%.

For the full year 2019, local currency sales growth is expected to be approximately 5%. This sales growth is expected to result in Adjusted EPS in the range of $22.65 to $22.70, an increase of 11% to 12%.

The Company said that based on its assessment of market conditions today, management anticipates local currency sales growth in 2020 will be approximately 4%. This sales growth is expected to result in Adjusted EPS in the range of $24.85 to $25.10. Using the mid-point of 2019 guidance, this would result in Adjusted EPS growth of 10% to 11%.

While the Company has provided an outlook for local currency sales growth and Adjusted EPS, it has not provided an outlook for reported sales growth or EPS as it would require an estimate of currency exchange fluctuations and non-recurring items, which are not yet known. The Company noted in making its outlook that uncertainty remains in the macroeconomic environment and market conditions are subject to change.

Conclusion

Filliol concluded, "We continue to benefit from our growth initiatives including investments in our field force, Spinnaker sales and marketing programs and new product launches. With the exception of Food Retail, demand in our markets is solid and we have generated good growth. As we look to 2020, we remain confident in the factors we can control – namely executing on our growth initiatives to continue to gain market share – but acknowledge greater uncertainty in the macroeconomic environment. We also believe that our margin and productivity initiatives will continue to yield tangible results. Based on market conditions today, we believe we can deliver strong results in 2019 and 2020."

Other Matters

The Company will host a conference call to discuss its quarterly results today (Thursday, November 7) at 5:00 p.m. Eastern Time. To hear a live webcast or replay of the call, visit the investor relations page on the Company’s website at www.mt.com/investors. The presentation referenced in the conference call will be located on the website prior to the call.

Titan Pharmaceuticals To Release Third Quarter 2019 Financial Results On November 14 – Conference Call To Follow

On November 7, 2019 Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) reported it will announce its third quarter 2019 financial results after market close on Thursday, November 14, 2019 (Press release, Titan Pharmaceuticals, NOV 7, 2019, View Source;conference-call-to-follow-300954308.html [SID1234550841]). Following the release, Titan management will host a conference call at 4:30 p.m. EST / 1:30 p.m. PST to review the financial results and discuss business developments in the period.

The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9174896. The call will also be broadcast live and archived on Titan’s website at www.titanpharm.com/news/events.

Amgen To Present At The 28th Annual Credit Suisse Healthcare Conference

On November 7, 2019 Amgen (NASDAQ:AMGN) reported that it will present at the 28th Annual Credit Suisse Healthcare Conference at 9:45 a.m. MT on Tuesday, Nov. 12, 2019, in Scottsdale, Ariz (Press release, Amgen, NOV 7, 2019, View Source [SID1234550840]). David W. Meline, executive vice president and chief financial officer at Amgen, will present at the conference . Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.