On August 6, 2019 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will be presenting at Canaccord Genuity’s 39th Annual Growth Conference on Wednesday, August 7, 2019, at 10:30 am ET. The conference will be held at the InterContinental Hotel in Boston, MA (Press release, Palatin Technologies, AUG 6, 2019, View Source [SID1234538234]).

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Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies, will provide an update on Palatin’s corporate and development programs, including:

Hypoactive Sexual Desire Disorder / Vyleesi (bremelanotide injection)
On June 21, 2019, the U.S. Food and Drug Administration (FDA) granted marketing approval of AMAG Pharmaceuticals, Inc’s New Drug Application (NDA) for Vyleesi, a melanocortin receptor agonist developed by Palatin, indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The Vyleesi autoinjector is the first treatment for this patient population that can be self-administered as needed in anticipation of sexual activity.
The FDA’s approval of the NDA triggered a $60 million milestone payment to Palatin (received July 2019) under its North American license agreement with AMAG.
AMAG is expected to launch Vyleesi nationally in September 2019.
Discussions with multiple parties on potential commercial partnerships for territories outside North America, China and South Korea are advancing.
Melanocortin Anti-Inflammatory / Autoimmune Programs under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis)
A Phase 2 proof-of-concept clinical study for PL-8177 with a systemic formulation in NIU patients is anticipated to commence in the first quarter of calendar year 2020.
A Phase 2 proof-of-concept clinical study for PL-8177 with an oral formulation in ulcerative colitis patients is anticipated to commence in the first quarter of calendar year 2020.
A Phase 2 clinical study for PL-9643 in dry eye disease is currently anticipated to commence in the first quarter of calendar year 2020. A recently completed Type B pre-IND (Investigational New Drug) meeting with the FDA established the development pathway for activities, including CMC, non-clinical studies and clinical studies, required for an NDA (New Drug Application) submission.
Cash and cash equivalents at June 30, 2019, on a pro forma basis, which includes the $60 million milestone payment by exclusive North American licensee, AMAG Pharmaceuticals, Inc., is approximately $102 million dollars.

On August 6, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, reported its financial results for the second quarter ended June 30, 2019 and provided an update on the company’s recent achievements and anticipated upcoming milestones (Press release, Audentes Therapeutics, AUG 6, 2019, View Source [SID1234538233]).

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"It is a very busy time at Audentes, and we are excited by the significant progress we have made across our portfolio," stated Matthew R. Patterson, Chairman and Chief Executive Officer. "Following collaborative interactions with FDA and EMA, we have initiated enrollment of eight additional XLMTM patients into an ASPIRO pivotal expansion cohort, which is designed to confirm the safety and efficacy profile of AT132 at a dose of 3×1014 vg/kg. We are optimistic that these data will support the submission of a BLA for AT132 in mid-2020."

Mr. Patterson continued, "We remain on track for a third quarter IND submission of AT845 for the treatment of Pompe disease. And importantly, we’ve made substantial progress advancing our DMD program. We expect patient dosing with NCH’s AT702 construct to commence as planned in the fourth quarter of 2019 and to submit an IND in the first quarter of 2020 for the Audentes AT702 construct, which is designed to serve as the platform for our rapid expansion into additional DMD genotypes next year. Together with our work in myotonic dystrophy, we believe this rich development pipeline positions us well for continued growth and industry leadership in the field of AAV-based genetic medicines for neuromuscular disease."

Recent Achievements & Upcoming Key Events

AT132 for XLMTM:

Positive data update from ASPIRO, the Phase 1/2 clinical trial of AT132 for the treatment of XLMTM, presented at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in May 2019.
3×1014 vg/kg selected as optimal dose.
Following collaborative interactions with the FDA and EMA, initiated enrollment of eight additional XLMTM patients into the ASPIRO pivotal expansion cohort, designed to confirm the safety and efficacy profile of AT132 at a dose of 3×1014 vg/kg.
Enrollment in the pivotal expansion cohort is expected to be complete in the fall of 2019.
BLA submission for AT132 planned in mid-2020; MAA submission planned for the second half of 2020.
Next clinical data presentation planned at the 24th International Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark, October 1-5, 2019.
Additional information on the ASPIRO Pivotal Expansion Cohort:

The pivotal expansion cohort is enrolling eight patients, consisting of four age-matched pairs (+/- 6 months), with one patient from each pair randomized to receive a single dose of AT132 (3×1014 vg/kg) or serve as a delayed treatment control. Delayed treatment control patients will be administered AT132 following the collection of 24-week data from the full pivotal cohort.
Patients will be followed for safety and efficacy for five years, with the primary analysis occurring 24 weeks post treatment.
Key inclusion criteria: less than 5 years of age or have been enrolled in INCEPTUS, on invasive ventilator support for 20-24 hours per day, unable to sit without assistance for at least 30 seconds.
The primary efficacy endpoint is defined as change from baseline in INCEPTUS, on invasive ventilator support for 20-24 hours per day, unable to sit without assistance for at least 30 seconds.
The primary efficacy endpoint is defined as change from baseline in hours of ventilatory support over time through week 24. As of the April 2019 ASPIRO data analysis, all nine patients treated achieved sustained and meaningful reductions in ventilatory support, with four patients successfully completely weaned off of mechanical ventilation.
AT845 for Pompe Disease:

Completed IND-enabling dose ranging and toxicology studies.
On track to submit IND in the third quarter of 2019.
AT702/AT751/AT753 for DMD:

Plan to commence patient dosing in the fourth quarter of 2019 with AT702 produced by NCH. AT702 is designed to induce exon 2 skipping to treat DMD caused by duplications of exon 2 (Dup2) and mutations in exons 1-5 of the dystrophin gene.
Dose ranging and toxicology studies underway to support a first quarter 2020 IND submission for the Audentes AT702 construct and transition the balance of the AT702 DMD program into a Phase 1/2 clinical study utilizing this product candidate.
The construct backbone of the Audentes AT702 product is designed to serve as a vectorized exon skipping platform for rapid expansion into additional DMD genotypes.
Preclinical work is underway to advance AT751 and AT753 to treat DMD patients with genotypes amenable to exons 51 and 53 skipping.
In combination, AT702, AT751 and AT753 have the potential to address more than 25% of DMD patients; plan to leverage our vectorized exon skipping platform to develop additional product candidates with the potential to address up to 80% of DMD patients over time.
AT466 for DM1:

Preclinical vector screening studies underway.
Plan to submit IND in 2020.
Manufacturing:

Advanced chemistry, manufacturing, and controls (CMC) BLA and MAA-readiness efforts for AT132.
State-of-the-art, internal, large-scale cGMP manufacturing facility provides sufficient capacity for AT132 global commercialization as well as the near-term clinical development of all pipeline programs.
Completed construction and commissioning of state-of-the-art, internal plasmid manufacturing facility to support production of nonclinical and cGMP-grade plasmids for all of our development programs, including the potential commercialization of AT132.
Corporate:

Appointed Edward R. Conner, M.D. as Senior Vice President and Chief Medical Officer. Ed is responsible for leading the company’s global clinical development strategy and oversees clinical development, clinical operations, regulatory affairs, medical affairs and patient advocacy.
Promoted Fulvio Mavilio, Ph.D. to Senior Vice President of Translational Science. Fulvio is responsible for advancing the company’s pipeline from discovery through to IND-enabling preclinical development and oversees discovery biology, pharmacology/toxicology, bioinformatics and bioanalytics.
Second Quarter 2019 Financial Results

Cash Position: As of June 30, 2019, cash, cash equivalents and marketable securities were $378.6 million.
Research and Development Expenses: Research and development expense was $37.3 million for the second quarter of 2019 compared to $26.3 million for the same period in 2018, an increase of $11.0 million. The increase was primarily attributable to higher direct program expenses for AT132 and AT845, along with additional R&D headcount to advance clinical and pre-clinical programs. Included in R&D expense for the three months ended June 30, 2019 was $3.2 million of non-cash stock-based compensation expense, compared to $2.3 million in the same period in 2018. For the six months ended June 30, 2019, research and development expense was $77.1 million compared to $46.2 million for the same period in 2018.
General and Administrative Expenses: General and administrative expense was $9.8 million for the second quarter of 2019 compared to $6.3 million for the same period in 2018. The increase was primarily attributable to headcount increases and infrastructure investment to support growth. Included in G&A expense for the three months ended June 30, 2019 was $2.9 million of non-cash stock-based compensation expense, compared to $1.8 million in the same period in 2018. For the six months ended June 30, 2019, general and administrative expense was $21.8 million compared to $12.8 million for the same period in 2018.
Net Loss: Net loss was $44.8 million for the second quarter of 2019 compared to $31.4 million for the same period in 2018. Basic and diluted net loss per share for the three months ended June 30, 2019, was $1.01 compared with $0.85 for the same period in 2018. For the six months ended June 30, 2019, net loss was $94.2 million compared to $56.9 million for the same period in 2018. Basic and diluted net loss per share for the six months ended June 30, 2019, was $2.14 compared with $1.59 for the same period in 2018.
Conference Call
At 4:30 p.m. Eastern Time today, Audentes management will host a conference call and a simultaneous webcast to discuss its second quarter 2019 financial results and provide a corporate update. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investors + Media section of the Audentes website at www.audentestx.com. Alternatively, please call (833) 659-8620 (U.S.) or (409) 767-9247 (international) and dial the conference ID# 4244738 to access the call.

A replay of the webcast will be available on the Audentes website for approximately 30 days.

On August 6, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the second quarter ending June 30, 2019 (Press release, PTC Therapeutics, AUG 6, 2019, View Source [SID1234538232]).

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"Over the second quarter we’ve made important progress towards our strategic plan of building a robust diversified orphan drug franchise," said Stuart W. Peltz, Ph.D., CEO of PTC Therapeutics. "We believe that one of PTC’s key differentiators is our ability to work across multiple scientific platforms to bring orphan products to patients. Our 5-year vision elucidates PTC’s mission of bringing differentiated therapies to patients living with rare disorders that have limited or no treatment options. By fulfilling this mission, we will be creating value for all of our stakeholders."

Key Second Quarter and Other Corporate Highlights:

Commercial portfolio

Translarna received approval from the Brazilian health regulatory authority (ANVISA) and subsequently, PTC has entered into its first annual contract with the Brazilian Ministry of Health.
Emflaza received FDA approval for a label expansion to include DMD patients aged 2-5 years. This demographic is estimated to comprise approximately 25% of the prevalent DMD population in the U.S.
First commercial patient on Tegsedi in Latin America received treatment. The regulatory application submitted to the Brazilian health regulatory authority (ANVISA) was granted priority review, with expected approval by year end 2019.
We are working with Akcea to review the recent clinical results for Waylivra in Familial Partial Lipodystrophy (FPL) and we will determine the potential commercial strategy in LATAM.
The CHMP adopted a negative opinion to expand the label for Translarna to include non-ambulatory DMD patients. PTC has requested a re-examination with a tentative date for an opinion in October.
Advancing gene therapy portfolio & infrastructure

PTC has signed a long-term lease agreement securing a state-of-the-art biologics facility to support the Company’s expansion into multiple gene therapy programs. The facility is currently operating under cGMP standards by its current tenant, Bristol-Myers Squibb, and will be fully transitioned to PTC by mid-2020. PTC intends to consolidate its discovery and research operations in the same campus.
The expected BLA for our gene therapy candidate to treat patients with AADC deficiency is on track for submission to the FDA in Q4 2019, with anticipated commercial launch in the U.S. in 2020.
PTC has expanded its gene therapy portfolio by entering into a strategic licensing agreement with Odylia Therapeutics for multiple preclinical programs to treat rare inherited retinal disorders. The lead program is for Leber Congenital Amaurosis (LCA6), a rare early onset retinal dystrophy.
Completed strategic equity investment in MRI Interventions provides PTC with devices that directly delivers gene therapies into the CNS.
Risdiplam remains on track for NDA submission with the FDA in 2H19

Data from pivotal FIREFISH and SUNFISH studies were presented at AAN and demonstrate continued clinical benefit with risdiplam in Type 1, 2, and 3 SMA.
Risdiplam continues to be well tolerated at all doses across studies and there have been no drug related safety findings leading to withdrawal.
Planned NDA filing with the FDA is on track for the second half of this year with the intention to support a broad label to treat SMA Types 1, 2, & 3 patients. Filing of the MAA in the EU is expected to occur in the first half of 2020.
PTC re-iterates full year 2019 guidance:

PTC anticipates full year DMD franchise net product revenues to be between $285 and $305 million.
PTC anticipates GAAP R&D and SG&A expense for the full year 2019 to be between $395 and $405 million.
PTC anticipates non-GAAP R&D and SG&A expense for the full year 2019 to be between $360 and $370 million, excluding estimated non-cash, stock-based compensation expense of approximately $35 million.
Second quarter 2019 financial highlights:

Total revenues were $85.5 million for the second quarter of 2019, compared to $68.7 million for the second quarter of 2018.
Translarna net product revenues were $57.8 million for the second quarter of 2019, compared to $47.8 million for the second quarter of 2018. These results reflect the expanded commercialization of Translarna.
Emflaza net product revenues were $27.6 million for the second quarter of 2019, compared to $20.3 million for the second quarter of 2018. These results reflect the continued transition to a new specialty pharmacy distributor.
GAAP R&D expenses were $60.0 million for the second quarter of 2019, compared to $32.6 million for the second quarter of 2018. The increase in R&D expenses reflects costs associated with advancing the gene therapy platform, increased investment in research programs and advancement of the clinical pipeline.
Non-GAAP R&D expenses were $54.5 million for the second quarter of 2019, excluding $5.5 million in non-cash, stock-based compensation expense, compared to $28.7 million for the second quarter of 2018, excluding $3.9 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $49.2 million for the second quarter of 2019, compared to $33.5 million for the second quarter of 2018. The increase in SG&A expenses reflects continued investment in commercial activities including our expanding commercial portfolio.
Non-GAAP SG&A expenses were $43.8 million for the second quarter of 2019, excluding $5.4 million in non-cash, stock-based compensation expense, compared to $29.4 million for the second quarter of 2018, excluding $4.1 million in non-cash, stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was $5.3 million for the second quarter of 2019. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
Net loss was $41.8 million for the second quarter of 2019, compared to net loss of $9.5 million for the second quarter of 2018.
Cash, cash equivalents, and marketable securities were $363.5 million at June 30, 2019, compared to $227.6 million at December 31, 2018.
Shares issued and outstanding as of June 30, 2019 were 58,707,185.
Non-GAAP Financial Measures:

In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating performance of PTC and the company’s future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the table below.

Today’s Conference Call and Webcast Reminder:

Today’s conference call will take place at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 6594813. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. The accompanying slide presentation will be posted on the investor relations section of the PTC website. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks.

On August 6, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Phase 1 study of its recombinant crisantaspase molecule, JZP-458, met its efficacy and safety objectives (Press release, Jazz Pharmaceuticals, AUG 6, 2019, View Source [SID1234538231]). The company plans to initiate a single-arm, pivotal Phase 2/3 study evaluating JZP-458 as a potential treatment option for patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase products.

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"Jazz is committed to the ALL patient community, and we are pleased to advance this development program with the goal of bringing a new treatment option to ALL and LBL patients who are hypersensitive to E. coli-derived asparaginase products as soon as possible," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "Following a meeting with the U.S. Food and Drug Administration, we are finalizing the Phase 2/3 study protocol in collaboration with the Children’s Oncology Group and plan to initiate the study later this year."

A recombinant crisantaspase Phase 1 study in healthy volunteers in the U.S. met safety and efficacy objectives with efficacy based on measurement of serum asparaginase activity levels. Results of this Phase 1 study will be submitted for presentation at an upcoming medical meeting.

About JZP-458
JZP-458 is a recombinant crisantaspase that uses a novel Pseudomonas fluorescens expression platform. It is being developed for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase products. A Phase 1 study of healthy volunteers was recently completed, and a single-arm, pivotal Phase 2/3 study is planned for initiation later in 2019.

About Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.1 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.2 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.3 The American Cancer Society estimates that almost 6,000 new cases of ALL will be diagnosed in the U.S. in 2019.4 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.5 However, asparaginase treatments derived from E. coli are associated with the development of hypersensitivity reactions.6

About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical company, is dedicated to developing life-changing medicines for people with limited or no options. As a leader in sleep medicine and with a growing hematology/oncology portfolio, Jazz has a diverse portfolio of products and product candidates in development, and is focused on transforming biopharmaceutical discoveries into novel medicines. Jazz Pharmaceuticals markets Sunosi (solriamfetol), Xyrem (sodium oxybate) oral solution, Defitelio (defibrotide sodium), Erwinaze (asparaginase Erwinia chrysanthemi) and Vyxeos (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Defitelio (defibrotide), Erwinase and Vyxeos 44 mg/100 mg powder for concentrate for solution for infusion in countries outside the U.S. For country-specific product information, please visit www.jazzpharmaceuticals.com/medicines. For more information, please visit www.jazzpharmaceuticals

On August 6, 2019 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, reported financial results for the second quarter ended June 30, 2019 (Press release, Penumbra, AUG 6, 2019, View Source [SID1234538230]).

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Revenue of $134.2 million in the second quarter of 2019, an increase of 22.4%, or 23.8% in constant currency1, over the second quarter of 2018.
Second Quarter 2019 Financial Results
Total revenue grew to $134.2 million for the second quarter of 2019 compared to $109.6 million for the second quarter of 2018, an increase of 22.4%, or 23.8% on a constant currency basis. The United States represented 64% of total revenue and international represented 36% of total revenue for the second quarter of 2019. Revenue from sales of neuro products grew to $81.5 million for the second quarter of 2019, an increase of 9.9%, or 11.5% on a constant currency basis. Revenue from sales of vascular products grew to $52.7 million for the second quarter of 2019, an increase of 48.6%, or 49.5% on a constant currency basis.

Gross profit was $93.9 million, or 70.0% of total revenue, for the second quarter of 2019, compared to $72.3 million, or 65.9% of total revenue, for the second quarter of 2018.

Total operating expenses for the second quarter of 2019 were $81.1 million, or 60.5% of total revenue. This compares to total operating expenses of $63.0 million, or 57.4% of total revenue, for the second quarter of 2018. R&D expenses were $13.5 million for the second quarter of 2019, compared to $8.2 million for the second quarter of 2018. SG&A expenses were $67.7 million for the second quarter of 2019, compared to $54.8 million for the second quarter of 2018.

Operating income for the second quarter of 2019 was $12.8 million, compared to operating income of $9.3 million for the second quarter of 2018.

Full Year 2019 Financial Outlook
The Company is increasing its 2019 guidance for total revenue to be in the range of $535 million to $540 million. This new range compares to the previous range of $525 million to $535 million.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss the second quarter 2019 financial results after market close on Tuesday, August 6, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone by dialing (866) 393-4306 for domestic callers or (734) 385-2616 for international callers (conference id: 9790865), 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.