AI
Wednesday, May 10, 2017 11:50:42 AM
Halozyme IS talking about Avid.II(Myford) in their 3-31-17/10Q pub. 5-9-17: “work associated with bringing on-line a 2nd contract mfg. facility. The validation of the new facility is scheduled to end in Q2/2017… Once this new facility is approved, it will become the primary source for Roche of bulk rHuPH20.”
HALO’s 3-31-17 10-Q filed 5-9-17: http://tinyurl.com/k6zb9uy (Halozyme)
Pg.41: "Product sales, net decreased in the 3mos ended 3-31-17 compared to the same period in 2016, due to a decrease in the sales of bulk rHuPH20 to Roche and a decrease in the sales of Hylenex. We expect that product sales of bulk rHuPH20 will fluctuate in future periods based on the needs of our collaborators. In 2016, we performed services for Roche to bring on-line a 2nd contract mfg. facility for bulk rHuPH20. Once this new facility is approved, it will become the primary source for Roche of bulk rHuPH20. As a result, we anticipate Roche will deplete their existing inventory of rHuPH20 ahead of the transition to the new facility, which will result in lower bulk product sales during 2017 & 2018. We expect that future product sales of Hylenex to be flat or experience modest growth, although there may be periods with declining revenue as we experience competition for market share.”
Pg.42: “Revenue from reimbursements for R&D services increased in the 3mos ended 3-31-17, 2017, compared to the same period in 2016 mainly due to an increase in services provided to Roche related to work associated with bringing on-line a 2nd contract mfg. facility. The validation of the new facility is scheduled to end in Q2/2017 and, therefore, we expect to see a decrease in R&D service revenue from Roche going forward. R&D services rendered by us on behalf of our collaborators are at the request of the collaborators; therefore, the amount and timing of future revenues related to reimbursable R&D services is uncertain.”
= = = = = = = = = = = = = = =All HALO Filings: http://tinyurl.com/k6zb9uy
PROOF:
HALO’s 12-31-16 10-K, iss. 2-28-17 (pg.12):
“In addition, we are working to scale-up, validate, and qualify a new facility operated by Avid [Avid II, “MYFORD”] as a manufacturer of bulk rHuPH20 for use in the products & product candidates under the Roche Collaboration.”
Pg.9: ROCHE COLLABORATION:
“In Dec. 2006, we and Roche entered into a collaboration & license agreement under which Roche obtained a worldwide, license to develop & commercialize product combinations of rHuPH20 and up to 13 Roche target compounds (the Roche Collaboration). Roche initially had the exclusive right to apply rHuPH20 to 3 pre-defined Roche biologic targets with the option to develop & commercialize rHuPH20 with 10 addl. targets. Roche had the right to exercise this option to identify addl. targets for 10 years. As of the 10 year anniversary of the Roche Collaboration in Dec. 2016, Roche had elected a total of 8 targets, 2 of which are exclusive.”
= = = = = = = = = = = = = = = = = = = = = = = =
3-13-17: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'17/Q3 (q/e 1-31-17): http://tinyurl.com/grhwjvy (since 5-2006: Avid=$213.3mm, Total=$239.9mm, incl.Govt)
......Avid FY17 (fye 4-30-17) revs guidance upped: $60-65mm; committed backlog=$70mm. Recently Leased +42,000sf in same bldg. as MYFORD for future expansion. Expect future sustainable profitability for the co. in 15mos.”
5-2017: Avid II (Myford) adds 2 MilliporeSigma Mobius 2,000L single-use bioreactors; total mfg. capacity now ">11,000L". http://tinyurl.com/ky7bmu4
2-28-17: Avid & Cook remain Halozyme's 2 CMO's (“working to scale-up/validate/qualify Avid II/Myford for Roche collab.”): http://tinyurl.com/h75teta
HALO’s 3-31-17 10-Q filed 5-9-17: http://tinyurl.com/k6zb9uy (Halozyme)
Pg.41: "Product sales, net decreased in the 3mos ended 3-31-17 compared to the same period in 2016, due to a decrease in the sales of bulk rHuPH20 to Roche and a decrease in the sales of Hylenex. We expect that product sales of bulk rHuPH20 will fluctuate in future periods based on the needs of our collaborators. In 2016, we performed services for Roche to bring on-line a 2nd contract mfg. facility for bulk rHuPH20. Once this new facility is approved, it will become the primary source for Roche of bulk rHuPH20. As a result, we anticipate Roche will deplete their existing inventory of rHuPH20 ahead of the transition to the new facility, which will result in lower bulk product sales during 2017 & 2018. We expect that future product sales of Hylenex to be flat or experience modest growth, although there may be periods with declining revenue as we experience competition for market share.”
Pg.42: “Revenue from reimbursements for R&D services increased in the 3mos ended 3-31-17, 2017, compared to the same period in 2016 mainly due to an increase in services provided to Roche related to work associated with bringing on-line a 2nd contract mfg. facility. The validation of the new facility is scheduled to end in Q2/2017 and, therefore, we expect to see a decrease in R&D service revenue from Roche going forward. R&D services rendered by us on behalf of our collaborators are at the request of the collaborators; therefore, the amount and timing of future revenues related to reimbursable R&D services is uncertain.”
= = = = = = = = = = = = = = =All HALO Filings: http://tinyurl.com/k6zb9uy
PROOF:
HALO’s 12-31-16 10-K, iss. 2-28-17 (pg.12):
“In addition, we are working to scale-up, validate, and qualify a new facility operated by Avid [Avid II, “MYFORD”] as a manufacturer of bulk rHuPH20 for use in the products & product candidates under the Roche Collaboration.”
Pg.9: ROCHE COLLABORATION:
“In Dec. 2006, we and Roche entered into a collaboration & license agreement under which Roche obtained a worldwide, license to develop & commercialize product combinations of rHuPH20 and up to 13 Roche target compounds (the Roche Collaboration). Roche initially had the exclusive right to apply rHuPH20 to 3 pre-defined Roche biologic targets with the option to develop & commercialize rHuPH20 with 10 addl. targets. Roche had the right to exercise this option to identify addl. targets for 10 years. As of the 10 year anniversary of the Roche Collaboration in Dec. 2016, Roche had elected a total of 8 targets, 2 of which are exclusive.”
= = = = = = = = = = = = = = = = = = = = = = = =
3-13-17: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'17/Q3 (q/e 1-31-17): http://tinyurl.com/grhwjvy (since 5-2006: Avid=$213.3mm, Total=$239.9mm, incl.Govt)
......Avid FY17 (fye 4-30-17) revs guidance upped: $60-65mm; committed backlog=$70mm. Recently Leased +42,000sf in same bldg. as MYFORD for future expansion. Expect future sustainable profitability for the co. in 15mos.”
5-2017: Avid II (Myford) adds 2 MilliporeSigma Mobius 2,000L single-use bioreactors; total mfg. capacity now ">11,000L". http://tinyurl.com/ky7bmu4
2-28-17: Avid & Cook remain Halozyme's 2 CMO's (“working to scale-up/validate/qualify Avid II/Myford for Roche collab.”): http://tinyurl.com/h75teta
